Devices › Analyzer, pacemaker generator function
Device brand name · Analyzer pacemaker generator function
CareLink SmartSync Base: medical device reports filed with FDA
1,864 reports name it, 2019–2026. Manufacturer given most often on reports: Medtronic. Product code DTC.
- 1,864
- device reports naming the brand
- 0% of all MAUDE reports · about 257 a year
- 227
- reports, 12 months to August 2026
- 322 in the 12 months before
- 94.1%
- classified as malfunction
- 95.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,864 reports that name the brand "CareLink SmartSync Base" (analyzer pacemaker generator function), received between April 2019 and August 2026; the manufacturer given most often on reports is Medtronic. Spellings of one product vary from report to report.
227 reports arrived in the 12 months to August 2026, down 30% from 322 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 (94.1%) and injury (5.9%); across all analyzer, pacemaker generator function reports (product code DTC) death is recorded in 0.1% and malfunction in 95.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are communication or transmission problem (37.9%), computer software problem (33.6%) and display or visual feedback problem (23.3%). The patient problems coded most often are asystole, bradycardia and cardiac arrest. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,841 reports carrying product code DTC. 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 |
|---|---|---|---|
| Communication or transmission problemthe device could not communicate or transmit | 707 | 37.9% | 25% |
| Computer software problema software problem | 627 | 33.6% | 44.7% |
| Display or visual feedback problem | 434 | 23.3% | 23.7% |
| Computer operating system problem | 424 | 22.7% | 28.5% |
| Output problem | 210 | 11.3% | 7.2% |
| Device difficult to program or calibrate | 101 | 5.4% | 3.5% |
| Pacing problem | 99 | 5.3% | 2.4% |
| Capturing problem | 94 | 5% | 3% |
| Device sensing problem | 82 | 4.4% | 2.3% |
| Data problem | 77 | 4.1% | 5.3% |
| Failure to interrogate | 58 | 3.1% | 3.3% |
| Inadequate user interface | 43 | 2.3% | 1.7% |
| Application program freezes or fails to launch | 26 | 1.4% | 0% |
| Failure to capture | 18 | 1% | 0.5% |
| Application program problem | 17 | 0.9% | 2.1% |
| Signal artifact/noise | 15 | 0.8% | 0.4% |
| Problem with software installation | 14 | 0.8% | 0.6% |
| Wireless communication problema wireless connection problem | 14 | 0.8% | 0.7% |
| Power problem | 13 | 0.7% | 0.5% |
| Impedance problem | 12 | 0.6% | 0.4% |
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 |
|---|---|---|
| Asystole | 28 | 1.5% |
| Bradycardiaslow heart rate | 10 | 0.5% |
| Cardiac arrestthe heart stopped | 9 | 0.5% |
| No patient involvement | 9 | 0.5% |
| Arrhythmia | 7 | 0.4% |
| Heart block | 7 | 0.4% |
| Tachycardiafast heart rate | 7 | 0.4% |
| Low blood pressure/ hypotension | 4 | 0.2% |
| Dizzinesslight-headedness or unsteadiness | 3 | 0.2% |
| Shock from patient lead(s) | 3 | 0.2% |
| Atrial fibrillationan irregular heart rhythm | 2 | 0.1% |
| Loss of consciousnesspassing out | 2 | 0.1% |
| Shockshock, a collapse of the circulation | 2 | 0.1% |
| Cardiac tamponade | 1 | 0.1% |
| Falla fall | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | CareLink SmartSync Base | Product code DTC | All MAUDE reports |
|---|---|---|---|
| Reports | 1,864 | 3,841 | 26,136,888 |
| Share of that pool | — | 48.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 5.9% | 3.9% | 36.2% |
| Classified as malfunction | 94.1% | 95.9% | 62.3% |
| Filed by the manufacturer | 100% | 98.6% | 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 DTC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CareLink SmartSync Common App iOS | 56,799 | 55,695 | 0% |
| Carelink Smartsync Platform Ios | 870 | 1 | 0% |
| Carelink | 15,005 | 18 | 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 SmartSync Base reports
How many FDA reports name CareLink SmartSync Base?
1,864 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 227 in the latest 12 months.
What kinds of events are reported?
malfunction (94.1%) and injury (5.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
communication or transmission problem (37.9%), computer software problem (33.6%), display or visual feedback problem (23.3%), computer operating system problem (22.7%) and output problem (11.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that CareLink SmartSync Base 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.