Devices › Defibrillator, implantable, dual-chamber
Device brand name · Implantable cardioverter defibrillator
Ovatio: medical device reports filed with FDA
675 reports name it, 2006–2018. Manufacturer given most often on reports: Sorin Crm. Product code MRM.
- 675
- device reports naming the brand
- 0% of all MAUDE reports · about 34 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 47.4%
- classified as malfunction
- 60% across the product code
- 3.3%
- classified as death, as reported
- 22 reports · not verified by FDA
FDA's MAUDE database holds 675 reports that name the brand "Ovatio" (implantable cardioverter defibrillator), received between August 2006 and June 2018; the manufacturer given most often on reports is Sorin Crm. 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 (47.4%), injury (44%) and other (4.9%); across all defibrillator, implantable, dual-chamber reports (product code MRM) death is recorded in 2.4% and malfunction in 60%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are over-sensing (23.7%), device remains implanted (15.9%) and inappropriate/inadequate shock/stimulation (11.7%). The patient problems coded most often are surgical procedure, shock and electric shock. 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 Ovatio was received in the five years to August 2026; the latest was received in June 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 7,873 reports carrying product code MRM. 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 |
|---|---|---|---|
| Over-sensing | 160 | 23.7% | 12.1% |
| Device remains implanted | 107 | 15.9% | 1.8% |
| Inappropriate/inadequate shock/stimulation | 79 | 11.7% | 7.2% |
| Explanted | 68 | 10.1% | 4.4% |
| High impedance | 43 | 6.4% | 2.9% |
| Other (for use when an appropriate device code cannot be identified) | 41 | 6.1% | 0.8% |
| Device displays incorrect message | 40 | 5.9% | 2.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 35 | 5.2% | 1.9% |
| Failure to interrogate | 26 | 3.9% | 5.9% |
| Pacemaker found in back-up mode | 23 | 3.4% | 1.7% |
| Under-sensing | 23 | 3.4% | 0.6% |
| Display or visual feedback problem | 22 | 3.3% | 1.4% |
| Defibrillation/stimulation problem | 20 | 3% | 1.2% |
| Incorrect interpretation of signal | 19 | 2.8% | 0.4% |
| Premature discharge of battery | 17 | 2.5% | 2.8% |
| Failure to deliver energy | 13 | 1.9% | 0.2% |
| Difficult to interrogate | 11 | 1.6% | 0.5% |
| Connection problema connection problem | 10 | 1.5% | 1.2% |
| Low impedance | 10 | 1.5% | 1.9% |
| Failure to convert rhythm | 8 | 1.2% | 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 |
|---|---|---|
| Surgical procedure | 68 | 10.1% |
| Shockshock, a collapse of the circulation | 26 | 3.9% |
| Electric shockan electric shock | 24 | 3.6% |
| Deaththe patient died; cause not stated by this term | 22 | 3.3% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 9 | 1.3% |
| Therapy/non-surgical treatment, unncessary | 7 | 1% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 7 | 1% |
| Loss of consciousnesspassing out | 6 | 0.9% |
| Shock from patient lead(s) | 6 | 0.9% |
| Discomfortdiscomfort | 5 | 0.7% |
| Atrial fibrillationan irregular heart rhythm | 4 | 0.6% |
| No patient involvement | 4 | 0.6% |
| Bradycardiaslow heart rate | 3 | 0.4% |
| Hospitalization required | 3 | 0.4% |
| Surgical procedure, additional | 3 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ovatio | Product code MRM | All MAUDE reports |
|---|---|---|---|
| Reports | 675 | 7,873 | 26,136,888 |
| Share of that pool | — | 8.6% | 0% |
| Classified as death, per 1,000 reports | 33 | 24 | 9 |
| Classified as injury | 44% | 36.1% | 36.2% |
| Classified as malfunction | 47.4% | 60% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 MRM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Paradym | 1,278 | 0 | 1.9% |
| Isoline | 598 | 6 | 0.8% |
| Platinium | 1,041 | 42 | 1.2% |
| Alto | 648 | 60 | 3.5% |
| Orchestra | 713 | 0 | 0.1% |
| Lumax 340 Hf-T | 186 | 0 | 9.7% |
| Paradym Rf | 241 | 0 | 1.7% |
| Lumax 540 Hf-T | 313 | 0 | 10.5% |
| SmartTouch | 668 | 132 | 0% |
| Lumax 340 Vr-T | 173 | 0 | 5.2% |
| Smartview | 317 | 5 | 0% |
| Lumax 540 Vr-T | 289 | 0 | 3.5% |
| Kora | 846 | 21 | 0% |
| Linox SD 65/16 | 1,288 | 31 | 1.2% |
| Linox Smart S 65 | 761 | 26 | 0.7% |
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 Ovatio reports
How many FDA reports name Ovatio?
675 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 (47.4%), injury (44%) and other (4.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
over-sensing (23.7%), device remains implanted (15.9%), inappropriate/inadequate shock/stimulation (11.7%), explanted (10.1%) and high impedance (6.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and distributor reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ovatio 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.