Electrode, pacemaker, temporary: medical device reports filed with FDA

2,032 reports carry this product code, 1992–2026; 9 brands with a page.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

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.

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

2,032
reports with this product code: 0% of all MAUDE reports; 156
reports, 12 months to August 2026: 158 in the 12 months before; 74%
classified as malfunction: 62.3% across all reports; 3.2%
classified as death, as reported: 0.9% across all reports

Product code LDF is FDA's classification for "Electrode, pacemaker, temporary" (cardiovascular panel), a class 2 device. 2,032 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

156 reports arrived in the 12 months to August 2026, close to the 158 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (74%), injury (21.8%) and death (3.2%). 9 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Swan-Ganz Bipolar Pacing Catheter For SVC Insertion	277	14	0%	92.9%
Swan-Ganz Bipolar Pacing Catheter For Femoral Insertion	164	2	0.4%	97.9%
Patient Cable	33	96	0%	89.5%
Medtronic	19	17	4.4%	23.5%
Transvenous	4	0	0.2%	27.6%
Ethicon	2	164	2.3%	54.2%
Swan-Ganz catheter	2	89	5.6%	78.3%
Tempo	1	155	0.7%	58.3%
Zoll	1	0	14%	36.7%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Edwards Lifesciences Pr	500	24.6%
Edwards Lifesciences	76	3.7%
C R Bard Covington -1018233	70	3.4%
Medtronic Heart Valves Division	50	2.5%
St Jude Medical	37	1.8%
Oscor	25	1.2%
Biosense Webster	23	1.1%
Medtronic Heart Valves	19	0.9%
Zoll Medical	8	0.4%
Biosense Webster Juarez	7	0.3%
Medtronic Heart Valve Division	5	0.2%
B Braun Surgical	3	0.1%
Bard	3	0.1%
Medtronic	3	0.1%
Physio-Control	3	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death3.2%66

Injury21.8%442

Malfunction74%1,503

Other0.5%11

Not given0.5%10

Who filed

Manufacturer report91.9%1,868

Voluntary report3.4%70

User facility report0%0

Distributor report0%0

Not given4.6%94

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Pacing problem	652	32.1%
Breakthe device broke	194	9.5%
Inflation problem	112	5.5%
No pacing	94	4.6%
Material separation	67	3.3%
Fracturea broken bone	54	2.7%
Material integrity problema problem with the device material	39	1.9%
Insufficient device problem information	32	1.6%
Replace	32	1.6%
Failure to capture	31	1.5%
Detachment of device component	27	1.3%
Detachment of device or device componentpart of the device came off	24	1.2%
Failure to sense	24	1.2%
Fluid/blood leak	24	1.2%
Material rupture	24	1.2%
Explanted	21	1%
Disconnection	20	1%
Patient device interaction problem	20	1%
Difficult to removethe device was hard to remove	19	0.9%
Connection problema connection problem	17	0.8%

Questions about electrode, pacemaker, temporary reports

What is product code LDF?

FDA's classification code for "Electrode, pacemaker, temporary", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,032 reports through August 2026, 156 of them in the latest 12 months.

Which brands appear most often?

Swan-Ganz Bipolar Pacing Catheter For SVC Insertion (277), Swan-Ganz Bipolar Pacing Catheter For Femoral Insertion (164), Patient Cable (33), Medtronic (19) and Transvenous (4). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.