Devices › Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Device brand name · Implantable chf generator
Contak Renewal: medical device reports filed with FDA
3,745 reports name it, 2003–2018. Manufacturer given most often on reports: Guidant Crm Clonmel Ireland. Product code NIK.
- 3,745
- device reports naming the brand
- 0% of all MAUDE reports · about 162 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 60.4%
- classified as malfunction
- 47.2% across the product code
- 4.8%
- classified as death, as reported
- 179 reports · not verified by FDA
3,745 medical device reports received by FDA name the brand "Contak Renewal" (implantable chf generator); the manufacturer given most often on reports is Guidant Crm Clonmel Ireland; received from May 2003 to October 2018. 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 malfunction (60.4%), injury (34.7%) and death (4.8%); across all defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) reports (product code NIK) death is recorded in 2.8% and malfunction in 47.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (15.1%), low battery (14.2%) and normal (11.8%). The patient problems coded most often are death, other (for use when an appropriate patient code cannot be identified) and surgical procedure, repeated. 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 Contak Renewal was received in the five years to August 2026; the latest was received in October 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 170,404 reports carrying product code NIK. 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 |
|---|---|---|---|
| Insufficient device problem information | 564 | 15.1% | 1.3% |
| Low battery | 532 | 14.2% | 2.4% |
| Normal | 442 | 11.8% | 0.8% |
| Pacing problem | 323 | 8.6% | 4.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 293 | 7.8% | 1.5% |
| High impedance | 293 | 7.8% | 5.6% |
| Over-sensing | 281 | 7.5% | 22.3% |
| Premature discharge of battery | 278 | 7.4% | 11% |
| Connection problema connection problem | 225 | 6% | 0.9% |
| Device sensing problem | 218 | 5.8% | 2.6% |
| Device displays incorrect message | 166 | 4.4% | 0.8% |
| Failure to capture | 135 | 3.6% | 4.1% |
| Noise | 127 | 3.4% | 0.5% |
| Inappropriate/inadequate shock/stimulation | 106 | 2.8% | 5.2% |
| Device alarm system | 101 | 2.7% | 0.3% |
| Alarm, error of warning | 79 | 2.1% | 0.2% |
| Battery problema problem with the battery | 72 | 1.9% | 1.8% |
| Material integrity problema problem with the device material | 66 | 1.8% | 0.3% |
| Defibrillation/stimulation problem | 65 | 1.7% | 0.7% |
| Protective measures problem | 55 | 1.5% | 0.2% |
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 | 170 | 4.5% |
| Other (for use when an appropriate patient code cannot be identified) | 129 | 3.4% |
| Surgical procedure, repeated | 93 | 2.5% |
| Syncopefainting | 74 | 2% |
| Cardiac arrestthe heart stopped | 37 | 1% |
| Pocket erosion | 34 | 0.9% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 33 | 0.9% |
| Asystole | 28 | 0.7% |
| Atrial fibrillationan irregular heart rhythm | 25 | 0.7% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 25 | 0.7% |
| Surgical procedure | 18 | 0.5% |
| Complaint, ill-defined | 17 | 0.5% |
| Arrhythmia | 11 | 0.3% |
| Dizzinesslight-headedness or unsteadiness | 8 | 0.2% |
| Bradycardiaslow heart rate | 6 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Contak Renewal | Product code NIK | All MAUDE reports |
|---|---|---|---|
| Reports | 3,745 | 170,404 | 26,136,888 |
| Share of that pool | — | 2.2% | 0% |
| Classified as death, per 1,000 reports | 48 | 28 | 9 |
| Classified as injury | 34.7% | 49.8% | 36.2% |
| Classified as malfunction | 60.4% | 47.2% | 62.3% |
| Filed by the manufacturer | 99.8% | 99.2% | 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 NIK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Quadra Assura MP ICD | 14,897 | 507 | 2.1% |
| Gallant HF | 8,971 | 1,918 | 0.7% |
| Quadra Assura Crt-D Quad Rf Hv | 7,971 | 14 | 2.5% |
| Quartet | 14,149 | 848 | 5.2% |
| Unify Assura CRT-D RF HV | 6,731 | 186 | 3.7% |
| Unify Crt-D | 5,907 | 10 | 3.4% |
| Consulta Crt-D | 4,623 | 0 | 5.9% |
| Unify Assura ICD | 4,511 | 127 | 1.6% |
| Claria MRI Quad CRT-D SureScan | 3,775 | 274 | 2.2% |
| Cognis | 8,694 | 6 | 1.5% |
| Protecta Xt Crt-D | 3,541 | 3 | 4.5% |
| Quadra Assura Ddqp+ | 3,349 | 0 | 2.3% |
| Cobalt XT HF Quad CRT-D MRI SureScan | 2,581 | 791 | 3% |
| Quadra Assura ICD | 2,526 | 67 | 0.8% |
| Vigilant X4 Crt-D | 2,275 | 482 | 0.9% |
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 Contak Renewal reports
How many FDA reports name Contak Renewal?
3,745 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 (60.4%), injury (34.7%) and death (4.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (15.1%), low battery (14.2%), normal (11.8%), pacing problem (8.6%) and device operates differently than expected (7.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Contak Renewal 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.