Programmer, pacemaker: medical device reports filed with FDA

24,211 reports carry this product code, 1992–2026; 26 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.

24,211
reports with this product code: 0.1% of all MAUDE reports; 973
reports, 12 months to August 2026: 1,052 in the 12 months before; 96.7%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code KRG is FDA's classification for "Programmer, pacemaker" (cardiovascular panel), a class 3 device. 24,211 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1992 to August 2026.

973 reports arrived in the 12 months to August 2026, close to the 1,052 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 (96.7%), injury (3.2%) and death (0.1%). 26 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	12,262	18	0%	97.9%
Carelink Programmer	6,264	546	0%	99.3%
CareLink Encore Programmer	1,343	103	0%	99.2%
Pacing System Analyzer	607	92	0%	98%
SmartTouch	590	132	0%	100%
Orchestra	536	0	0.1%	99%
Merlin Programmer	518	26	0.1%	92.8%
Vitality 2	399	0	1%	61.4%
Carelink Encore	317	0	0%	98.4%
Medtronic Carelink Programmer With Analyzer	173	31	0%	99.4%
Vitality	171	0	0.9%	64.1%
Zoom	150	3	0%	94.6%
N'vision	33	0	0.7%	50.2%
Vitality Avt	6	0	2.3%	70.9%
Carelink System	4	0	0.3%	98.3%
Carelink Program W/Telemetry C	3	0	0%	99.2%
Vitality Ds Vr Is-1/Df-1 Vvir	3	0	0%	79.7%
Kora	2	21	0%	98.9%
S-Icd System	2	0	1.1%	30.3%
Vitality 2 Vr El Is-1/Df-1	2	0	0%	53%
Alizea	1	50	0.7%	97.5%
Eno	1	43	0%	97.4%
Merlin@home, RF telemetry basic	1	45	0.1%	98.4%
Synchromed El	1	2	4.9%	29.8%
Target Tip	1	8	8.3%	32.3%
Vitality 2 Vr Is-1/Df-1	1	0	0.2%	65.7%

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
Medtronic	20,667	85.4%
Microport Crm	603	2.5%
Guidant Crm Clonmel Ireland	587	2.4%
Sorin Group Italia - Crm Facility	554	2.3%
Plexus Manufacturing Sdn Bhd	525	2.2%
St Jude Medical Crm-Sunnyvale	143	0.6%
Medtronic Milaca	75	0.3%
St Jude Medical Crm-Sylmar	74	0.3%
Rice Creek Mfg	60	0.2%
Sulzer Intermedics	31	0.1%
Boston Scientific	11	0%
Medtronic Puerto Rico	11	0%
St Jude Medical Cardiac Rhythm Management Division	11	0%
Sorin Crm	10	0%
Guidant Puerto Rico	9	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

Death0.1%14

Injury3.2%780

Malfunction96.7%23,405

Other0%8

Not given0%4

Who filed

Manufacturer report99.9%24,184

Voluntary report0.1%19

User facility report0%0

Distributor report0%0

Not given0%8

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

Device problems coded

Device problem (FDA code)	Reports	Share
Device difficult to program or calibrate	3,389	14%
No display/image	3,122	12.9%
Communication or transmission problemthe device could not communicate or transmit	2,206	9.1%
Electrical /electronic property probleman electrical or electronic problem	2,039	8.4%
Computer operating system problem	2,010	8.3%
Computer software problema software problem	1,744	7.2%
Output problem	1,609	6.6%
Display or visual feedback problem	1,592	6.6%
Failure to calibrate	1,110	4.6%
Mechanical problema mechanical problem	971	4%
Failure to power up	869	3.6%
Device operates differently than expectedthe device behaved unexpectedly	822	3.4%
Failure to interrogate	759	3.1%
Unexpected shutdown	754	3.1%
Power problem	705	2.9%
Connection problema connection problem	692	2.9%
Overheating of device	639	2.6%
Inadequate user interface	605	2.5%
Device displays incorrect message	558	2.3%
Problem with software installation	476	2%

Questions about programmer, pacemaker reports

What is product code KRG?

FDA's classification code for "Programmer, pacemaker", class 3, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

24,211 reports through August 2026, 973 of them in the latest 12 months.

Which brands appear most often?

Carelink (12,262), Carelink Programmer (6,264), CareLink Encore Programmer (1,343), Pacing System Analyzer (607) and SmartTouch (590). 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.