Device brand name · Programmer pacemaker

Carelink Encore: medical device reports filed with FDA

368 reports name it, 2014–2019. Manufacturer given most often on reports: Plexus Manufacturing Sdn Bhd. Product code KRG.

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.

368
device reports naming the brand: 0% of all MAUDE reports · about 30 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 98.4%
classified as malfunction: 96.7% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 368 reports that name the brand "Carelink Encore" (programmer pacemaker), received between June 2014 and May 2019; the manufacturer given most often on reports is Plexus Manufacturing Sdn Bhd. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (98.4%) and injury (1.6%); across all programmer, pacemaker reports (product code KRG) death is recorded in 0.1% and malfunction in 96.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are computer operating system problem (28.8%), power problem (28.8%) and computer software problem (18.5%). The patient problems coded most often are no patient involvement and syncope. 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."

Reports by month, five years

No report naming Carelink Encore was received in the five years to August 2026; the latest was received in May 2019.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury1.6%6

Malfunction98.4%362

Other0%0

Not given0%0

Who filed the report

Manufacturer report99.7%367

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0.3%1

Grey bar: all 24,211 reports carrying product code KRG. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Computer operating system problem	106	28.8%	8.3%
Power problem	106	28.8%	2.9%
Computer software problema software problem	68	18.5%	7.2%
No display/image	57	15.5%	12.9%
Battery problema problem with the battery	38	10.3%	0.5%
Failure to power up	36	9.8%	3.6%
Device difficult to program or calibrate	31	8.4%	14%
Unexpected shutdown	24	6.5%	3.1%
Failure to interrogate	17	4.6%	3.1%
Overheating of device	17	4.6%	2.6%
Communication or transmission problemthe device could not communicate or transmit	13	3.5%	9.1%
Inadequate user interface	13	3.5%	2.5%
Output problem	11	3%	6.6%
Connection problema connection problem	8	2.2%	2.9%
Failure to calibrate	8	2.2%	4.6%
Operating system becomes nonfunctional	7	1.9%	1.5%
Problem with software installation	7	1.9%	2%
Mechanical problema mechanical problem	6	1.6%	4%
Data problem	5	1.4%	1.4%
Failure to shut off	4	1.1%	0.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
No patient involvement	149	40.5%
Syncopefainting	1	0.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Carelink Encore	Product code KRG	All MAUDE reports
Reports	368	24,211	26,136,888
Share of that pool	—	1.5%	0%
Classified as death, per 1,000 reports	0	1	9
Classified as injury	1.6%	3.2%	36.2%
Classified as malfunction	98.4%	96.7%	62.3%
Filed by the manufacturer	99.7%	99.9%	94.9%

Shares are of reports, not of devices in use. 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."

Other brands with product code KRG

Brand	Reports	Latest 12 months	Classified as death
Carelink	15,005	18	0%
Carelink Programmer	6,264	546	0%
CareLink Encore Programmer	1,343	103	0%
Pacing System Analyzer	607	92	0%
SmartTouch	668	132	0%
Orchestra	713	0	0.1%
Merlin Programmer	1,425	26	0.1%
Vitality 2	4,779	0	1%
Medtronic Carelink Programmer With Analyzer	173	31	0%
Vitality	2,095	0	0.9%
Zoom	441	3	0%
N'vision	269	0	0.7%
Vitality Avt	1,235	0	2.3%
Carelink System	343	0	0.3%
Carelink Program W/Telemetry C	1,681	0	0%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Carelink Encore reports

How many FDA reports name Carelink Encore?

368 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (98.4%) and injury (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

computer operating system problem (28.8%), power problem (28.8%), computer software problem (18.5%), no display/image (15.5%) and battery problem (10.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Carelink Encore was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.