Pacemaker/icd/crt non-implanted components: medical device reports filed with FDA

58,914 reports carry this product code, 2013–2026; 17 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.

58,914
reports with this product code: 0.2% of all MAUDE reports; 56,359
reports, 12 months to August 2026: 523 in the 12 months before; 99.8%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code OSR is FDA's classification for "Pacemaker/icd/crt non-implanted components" (unknown panel), a class 3 device. 58,914 medical device reports carry this product code, 0.2% of the MAUDE database, from March 2013 to August 2026.

56,359 reports arrived in the 12 months to August 2026, up 10676% from 523 in 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 (99.8%) and injury (0.2%). 17 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
CareLink SmartSync Common App iOS	55,789	55,695	0%	99.9%
LATITUDE Programming System	1,322	108	0%	98.6%
CareLink SmartSync Base	264	227	0%	94.1%
Smart Monitor	257	32	0%	100%
Smartview	176	5	0%	99.7%
LATITUDE Communicator	108	60	0%	99.1%
Patient Connector	90	83	0%	96.1%
Communicator	56	0	0%	98.8%
Carelink Encore	50	0	0%	98.4%
SmartTouch	32	132	0%	100%
Autogen	13	212	1%	52.2%
Merlin Net / Hf Portal	7	34	0%	98.5%
MyCareLink Patient Monitor	3	47	0.1%	99.6%
Screwdriver	2	15	0%	87.6%
Altrua 60	1	29	0.6%	32.2%
Carelink Smartsync Platform Ios	1	1	0%	97.1%
Zoom	1	3	0%	94.6%

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
Medtronic	56,126	95.3%
Microport Crm	487	0.8%
Sorin Group Italia - Crm Facility	205	0.3%
Plexus Manufacturing Sdn Bhd	47	0.1%
Biotronik Se & Kg	21	0%
Guidant Crm Clonmel Ireland	14	0%
Medtronic Milaca	4	0%
St Jude Medical - Cardiomems	2	0%

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

Death0%2

Injury0.2%94

Malfunction99.8%58,813

Other0%4

Not given0%1

Who filed

Manufacturer report100%58,891

Voluntary report0%21

User facility report0%0

Distributor report0%0

Not given0%2

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

Device problems coded

Device problem (FDA code)	Reports	Share
Computer operating system problem	43,166	73.3%
Computer software problema software problem	40,809	69.3%
Display or visual feedback problem	1,763	3%
Communication or transmission problemthe device could not communicate or transmit	1,278	2.2%
Key or button unresponsive/not working	1,078	1.8%
Defective devicethe device was defective	742	1.3%
Output problem	208	0.4%
Application program problem	167	0.3%
Data problem	163	0.3%
Application program freezes or fails to launch	136	0.2%
Wireless communication problema wireless connection problem	98	0.2%
Power problem	92	0.2%
Failure to power up	81	0.1%
Inadequate user interface	71	0.1%
Device operates differently than expectedthe device behaved unexpectedly	65	0.1%
Pacing problem	38	0.1%
Device difficult to program or calibrate	37	0.1%
Failure to interrogate	36	0.1%
Connection problema connection problem	35	0.1%
Defective component	35	0.1%

Questions about pacemaker/icd/crt non-implanted components reports

What is product code OSR?

FDA's classification code for "Pacemaker/icd/crt non-implanted components", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

58,914 reports through August 2026, 56,359 of them in the latest 12 months.

Which brands appear most often?

CareLink SmartSync Common App iOS (55,789), LATITUDE Programming System (1,322), CareLink SmartSync Base (264), Smart Monitor (257) and Smartview (176). 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.