Devices › Implantable pacemaker pulse-generator
Device brand name · Implantable pulse generator
Sigma 100 Vvi: medical device reports filed with FDA
354 reports name it, 2003–2017. Manufacturer given most often on reports: Medtronic Of Canada. Product code DXY.
- 354
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 7.6%
- classified as malfunction
- 41.2% across the product code
- 1.4%
- classified as death, as reported
- 5 reports · not verified by FDA
354 medical device reports received by FDA name the brand "Sigma 100 Vvi" (implantable pulse generator); the manufacturer given most often on reports is Medtronic Of Canada; received from March 2003 to December 2017. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (90.4%), malfunction (7.6%) and death (1.4%); 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 premature discharge of battery (35.9%), low battery (21.2%) and difficult to interrogate (13.8%). The patient problems coded most often are dizziness, syncope and fainting. 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 Sigma 100 Vvi was received in the five years to August 2026; the latest was received in December 2017.
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 |
|---|---|---|---|
| Premature discharge of battery | 127 | 35.9% | 8.4% |
| Low battery | 75 | 21.2% | 5.3% |
| Difficult to interrogate | 49 | 13.8% | 3.1% |
| No device output | 39 | 11% | 4.8% |
| Failure to interrogate | 30 | 8.5% | 6.1% |
| Pacing problem | 18 | 5.1% | 6.4% |
| Other (for use when an appropriate device code cannot be identified) | 14 | 4% | 4.5% |
| Communication or transmission problemthe device could not communicate or transmit | 7 | 2% | 1.2% |
| Premature elective replacement indicator | 6 | 1.7% | 2.2% |
| Battery problema problem with the battery | 5 | 1.4% | 0.5% |
| Failure to capture | 5 | 1.4% | 6.3% |
| High impedance | 5 | 1.4% | 3.8% |
| Defective devicethe device was defective | 3 | 0.8% | 0.5% |
| Mechanical problema mechanical problem | 3 | 0.8% | 1.4% |
| No pacing | 3 | 0.8% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.6% | 1.8% |
| Failure to fire | 2 | 0.6% | 0.1% |
| Inappropriate or unexpected reset | 2 | 0.6% | 0.3% |
| Insufficient device problem information | 2 | 0.6% | 0.9% |
| Loose or intermittent connection | 2 | 0.6% | 0.6% |
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 |
|---|---|---|
| Dizzinesslight-headedness or unsteadiness | 19 | 5.4% |
| Syncopefainting | 19 | 5.4% |
| Fainting | 10 | 2.8% |
| Bradycardiaslow heart rate | 9 | 2.5% |
| Heart rate, decreased | 5 | 1.4% |
| Deaththe patient died; cause not stated by this term | 4 | 1.1% |
| Chest tightness/pressure | 3 | 0.8% |
| Complaint, ill-defined | 2 | 0.6% |
| Discomfortdiscomfort | 2 | 0.6% |
| Dyspneashortness of breath | 2 | 0.6% |
| Failure of implant | 2 | 0.6% |
| Falla fall | 2 | 0.6% |
| Loss of consciousnesspassing out | 2 | 0.6% |
| Asystole | 1 | 0.3% |
| Bruise/contusion | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sigma 100 Vvi | Product code DXY | All MAUDE reports |
|---|---|---|---|
| Reports | 354 | 57,832 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 14 | 34 | 9 |
| Classified as injury | 90.4% | 54.4% | 36.2% |
| Classified as malfunction | 7.6% | 41.2% | 62.3% |
| Filed by the manufacturer | 100% | 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 Sigma 100 Vvi reports
How many FDA reports name Sigma 100 Vvi?
354 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 (90.4%), malfunction (7.6%) and death (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature discharge of battery (35.9%), low battery (21.2%), difficult to interrogate (13.8%), no device output (11%) and failure to interrogate (8.5%). 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 Sigma 100 Vvi 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.