Devices › Implantable pacemaker pulse-generator
Device brand name · Implantable pulse generator
Insync: medical device reports filed with FDA
150 reports name it, 2002–2016. Manufacturer given most often on reports: Medtronic. Product code DXY.
- 150
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 17.3%
- classified as malfunction
- 41.2% across the product code
- 15.3%
- classified as death, as reported
- 23 reports · not verified by FDA
FDA's MAUDE database holds 150 reports that name the brand "Insync" (implantable pulse generator), received between January 2002 and June 2016; the manufacturer given most often on reports is Medtronic. 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 injury (67.3%), malfunction (17.3%) and death (15.3%); across all implantable pacemaker pulse-generator reports (product code DXY) death is recorded in 3.4% and malfunction in 41.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are other (for use when an appropriate device code cannot be identified) (10%), reset problem (8%) and device remains activated (4.7%). The patient problems coded most often are death, sepsis and muscle stimulation. 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 Insync was received in the five years to August 2026; the latest was received in June 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 57,832 reports carrying product code DXY. 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 |
|---|---|---|---|
| Other (for use when an appropriate device code cannot be identified) | 15 | 10% | 4.5% |
| Reset problem | 12 | 8% | 1.5% |
| Device remains activated | 7 | 4.7% | 1.1% |
| Inappropriate or unexpected reset | 6 | 4% | 0.3% |
| Low battery | 5 | 3.3% | 5.3% |
| Failure to interrogate | 4 | 2.7% | 6.1% |
| High impedance | 4 | 2.7% | 3.8% |
| Failure to capture | 3 | 2% | 6.3% |
| Mechanical problema mechanical problem | 3 | 2% | 1.4% |
| Battery problema problem with the battery | 2 | 1.3% | 0.5% |
| Defective devicethe device was defective | 2 | 1.3% | 0.5% |
| Device contamination with body fluid | 2 | 1.3% | 0.1% |
| Elective replacement | 2 | 1.3% | 0.3% |
| Electromagnetic interference | 2 | 1.3% | 0.6% |
| Extracardiac stimulation | 2 | 1.3% | 0.3% |
| Intermittent capture | 2 | 1.3% | 0.8% |
| No device output | 2 | 1.3% | 4.8% |
| Over-sensing | 2 | 1.3% | 5.4% |
| Pacing problem | 2 | 1.3% | 6.4% |
| Capturing problem | 1 | 0.7% | 0.7% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 19 | 12.7% |
| Sepsisa severe body-wide response to infection | 8 | 5.3% |
| Muscle stimulation | 5 | 3.3% |
| Multiple organ dysfunction syndromeseveral organs failing | 2 | 1.3% |
| Syncopefainting | 2 | 1.3% |
| Asystole | 1 | 0.7% |
| Breathing difficulties | 1 | 0.7% |
| Cardiomyopathydisease of the heart muscle | 1 | 0.7% |
| Congestive heart failure | 1 | 0.7% |
| Discomfortdiscomfort | 1 | 0.7% |
| Erosion | 1 | 0.7% |
| Fever | 1 | 0.7% |
| Heart failure | 1 | 0.7% |
| Necrosisdeath of tissue | 1 | 0.7% |
| Purulent discharge | 1 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Insync | Product code DXY | All MAUDE reports |
|---|---|---|---|
| Reports | 150 | 57,832 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 153 | 34 | 9 |
| Classified as injury | 67.3% | 54.4% | 36.2% |
| Classified as malfunction | 17.3% | 41.2% | 62.3% |
| Filed by the manufacturer | 98% | 96.6% | 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 DXY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Tendril Mri | 7,076 | 422 | 4.1% |
| Medtronic Lead | 2,351 | 328 | 9.5% |
| Carelink Program W/Telemetry C | 1,681 | 0 | 0% |
| Carelink | 15,005 | 18 | 0% |
| Assurity Mri | 18,995 | 2,035 | 1.8% |
| Insignia Plus | 940 | 0 | 9.1% |
| Insignia Ultra | 797 | 0 | 5.4% |
| Meta Dddr | 532 | 0 | 0.4% |
| Enpulse | 606 | 3 | 10.4% |
| Medtronic ICD | 404 | 105 | 23.8% |
| Insignia Entra | 374 | 0 | 10.2% |
| Anthem Rf | 372 | 0 | 4.3% |
| Tempo | 721 | 155 | 0.7% |
| Medtronic | 2,953 | 17 | 4.4% |
| Symphony | 1,163 | 133 | 1.6% |
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." 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 Insync reports
How many FDA reports name Insync?
150 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?
injury (67.3%), malfunction (17.3%) and death (15.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
other (for use when an appropriate device code cannot be identified) (10%), reset problem (8%), device remains activated (4.7%), inappropriate or unexpected reset (4%) and low battery (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98%) and voluntary reports (2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Insync 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.