Medical device complication adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: a complication with the device

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to December 2015, FDA received 7,380 adverse event reports that record the MedDRA preferred term Medical device complication. In plain words, the term means: a complication with the device. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports for female patients were 79.3% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Plain meaning

A complication with the device. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 111 drug pages with 5 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Medical device complication name as a suspect product, in order of name
Drug	Class	Reports with this term
Actonel	Bisphosphonate	14
Alendronate sodium	Bisphosphonate	45
Ambrisentan	Endothelin receptor antagonist	18
Angiomax		5
Aprepitant	Substance P/Neurokinin-1 receptor antagonist	6
Aspirin	Nonsteroidal anti-inflammatory drug	7
Avonex	Interferon beta	55
Baclofen	gamma-Aminobutyric acid-ergic agonist	67
Bevacizumab	Vascular endothelial growth factor inhibitor	11
Bextra		5
Boniva		16
Bupivacaine	Amide local anesthetic	20
Byetta	GLP-1 receptor agonist	13
Carboplatin	Platinum-based drug	11
Celebrex	Nonsteroidal anti-inflammatory drug	9
Cetuximab	Epidermal growth factor receptor antagonist	5
Cinryze	Human C1 esterase inhibitor	16
Cisplatin	Platinum-based drug	12
Clonidine	Central alpha-2 adrenergic agonist	11
Cytarabine	Nucleoside metabolic inhibitor	6
Delflex	Osmotic laxative	6
Dexamethasone	Corticosteroid	13
Dianeal		79
Dianeal Low Calcium		27
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		30
Diastat		7
Dilaudid	Opioid agonist	13
Doxorubicin	Anthracycline topoisomerase inhibitor	6
Duodopa		7
Duragesic		6
Enbrel	Tumor necrosis factor blocker	45
Epinephrine	Catecholamine	5
Etonogestrel Implant- Unknown		23
Evista	Estrogen Agonist/Antagonist	7
Extraneal	Osmotic laxative	15
Fentanyl	Opioid agonist	7
Fentanyl Transdermal System		8
Flolan		110
Forsteo		6
Forteo	Parathyroid hormone analog	120
Fosamax	Bisphosphonate	104
Fosamax Plus D		19
Fragmin	Anti-coagulant	6
Gattex	GLP-2 analog	6
Gleevec	Kinase inhibitor	6
Heparin		8
Heparin sodium	Anti-coagulant	15
Humalog	Insulin analog	59
Humalog Mix 75/25		10
Humatrope		11
Humira		87
Humulin 70/30	Insulin	16
Humulin N	Insulin	28
Humulin R	Insulin	14
Ifosfamide	Alkylating drug	6
Implanon		1,335
Implanon Nxt		5
Infumorph		21
Inomax	Vasodilator	5
Invega Sustenna	Atypical antipsychotic	8
Januvia	Dipeptidyl peptidase 4 inhibitor	7
Lantus	Insulin analog	29
Letairis	Endothelin receptor antagonist	68
Lioresal (baclofen)	gamma-Aminobutyric acid-ergic agonist	274
Lioresal Intrathecal		8
Mabthera		5
Methotrexate	Folate analog metabolic inhibitor	10
Mirena	Progestin	1,376
Mirena Iud		10
Morphine	Opioid agonist	18
Morphine sulfate	Opioid agonist	6
Naglazyme	Hydrolytic lysosomal glycosaminoglycan-specific enzyme	7
Neurontin		6
Nexium	Proton pump inhibitor	7
Nexplanon	Progestin	736
Novolog	Insulin analog	5
NovoSeven		8
Nutropin Aq		7
Nuvaring	Estrogen	85
Ondansetron	Serotonin-3 receptor antagonist	5
Opsumit	Endothelin receptor antagonist	8
Opticlik		14
Oxaliplatin	Platinum-based drug	8
Paragard 380a		395
ParaGard T 380A	Copper-containing intrauterine device	219
Paragard T380a		43
Pegintron		7
Pradaxa	Direct thrombin inhibitor	13
Prednisone	Corticosteroid	10
Proair Hfa		10
Prograf	Calcineurin inhibitor immunosuppressant	6
Provenge		5
Rebif	Interferon beta	9
Remicade	Tumor necrosis factor blocker	24
Remodulin	Prostacycline vasodilator	99
Revatio	Phosphodiesterase 5 inhibitor	8
Revlimid	Thalidomide analog	9
Risperdal Consta		49
Simponi	Tumor necrosis factor blocker	37
Soliris	Complement inhibitor	12
Taxol		42
Tecfidera		6
Thalomid		6
Tracleer	Endothelin receptor antagonist	54
Tysabri	Integrin receptor antagonist	58
Tyvaso	Prostacycline vasodilator	11
Veletri	Prostacycline vasodilator	40
Vioxx		8
Xalatan	Prostaglandin analog	8
Xarelto	Factor Xa inhibitor	9
Zemplar	Vitamin D analog	10

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 52 pharmacologic classes with 5 or more reports that record this term. The rows are in order of name.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Medical device complication name, in order of name
Class	Reports with this term
Alkylating drug	12
Amide local anesthetic	27
Anthracycline topoisomerase inhibitor	8
Anti-coagulant	21
Anticholinergic	5
Atypical antipsychotic	19
Bisphosphonate	163
Calcineurin inhibitor immunosuppressant	10
Catecholamine	5
Central alpha-2 adrenergic agonist	11
Complement inhibitor	12
Copper-containing intrauterine device	219
Corticosteroid	41
Dipeptidyl peptidase 4 inhibitor	7
Direct thrombin inhibitor	13
Endothelin receptor antagonist	150
Epidermal growth factor receptor antagonist	5
Estrogen	88
Estrogen Agonist/Antagonist	7
Factor Xa inhibitor	11
Folate analog metabolic inhibitor	10
gamma-Aminobutyric acid-ergic agonist	343
GLP-1 receptor agonist	13
GLP-2 analog	6
HMG-CoA reductase inhibitor	6
Human C1 esterase inhibitor	16
Hydrolytic lysosomal glucocerebroside-specific enzyme	6
Hydrolytic lysosomal glycosaminoglycan-specific enzyme	13
Insulin	58
Insulin analog	100
Integrin receptor antagonist	58
Interferon beta	64
Kinase inhibitor	24
Nonsteroidal anti-inflammatory drug	18
Nucleoside metabolic inhibitor	14
Opioid agonist	48
Osmotic laxative	27
Parathyroid hormone analog	120
Phosphodiesterase 5 inhibitor	11
Platinum-based drug	31
Progestin	2,112
Prostacycline vasodilator	150
Prostaglandin analog	10
Proton pump inhibitor	7
Serotonin-3 receptor antagonist	5
Substance P/Neurokinin-1 receptor antagonist	6
Thalidomide analog	9
Tumor necrosis factor blocker	108
Vascular endothelial growth factor inhibitor	15
Vasodilator	5
Vitamin D analog	10
Vitamin K antagonist	6

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Medical device complication, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Medical device complication
Age	Reports	Share
Under 2	37	0.5%
2 to 11	83	1.1%
12 to 17	176	2.4%
18 to 44	2,482	33.6%
45 to 64	817	11.1%
65 to 74	325	4.4%
75 and over	294	4%
Age not given	3,166	42.9%

Sex of the patient in the reports that record Medical device complication
Sex	Reports	Share
Female	5,856	79.3%
Male	1,158	15.7%
Unknown or not given	366	5%

Age and sex are as the report gives them. 85.4% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Medical device complication: adverse event reports that record this term. https://reportedreactions.com/reaction/medical-device-complication/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Medical device complication mean in an adverse event report?

In plain words: a complication with the device. It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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