Devices › Defibrillator, implantable, dual-chamber
Device brand name · Defibrillator implantable dual-chamber
Platinium: medical device reports filed with FDA
1,041 reports name it, 2016–2026. Manufacturer given most often on reports: Sorin Group Italia - Crm Facility. Product code MRM.
- 1,041
- device reports naming the brand
- 0% of all MAUDE reports · about 103 a year
- 42
- reports, 12 months to August 2026
- 38 in the 12 months before
- 72.7%
- classified as malfunction
- 60% across the product code
- 1.2%
- classified as death, as reported
- 13 reports · not verified by FDA
1,041 medical device reports received by FDA name the brand "Platinium" (defibrillator implantable dual-chamber); the manufacturer given most often on reports is Sorin Group Italia - Crm Facility; received from June 2016 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
42 reports arrived in the 12 months to August 2026, up 11% from 38 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 (72.7%), injury (26%) and death (1.2%); 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 (22.9%), inappropriate/inadequate shock/stimulation (7.7%) and premature discharge of battery (7.5%). The patient problems coded most often are death, no patient involvement and shock from patient lead(s). 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 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 | 238 | 22.9% | 12.1% |
| Inappropriate/inadequate shock/stimulation | 80 | 7.7% | 7.2% |
| Premature discharge of battery | 78 | 7.5% | 2.8% |
| Communication or transmission problemthe device could not communicate or transmit | 61 | 5.9% | 1.1% |
| Failure to interrogate | 57 | 5.5% | 5.9% |
| High impedance | 55 | 5.3% | 2.9% |
| Display or visual feedback problem | 39 | 3.7% | 1.4% |
| Device displays incorrect message | 36 | 3.5% | 2.5% |
| Data problem | 27 | 2.6% | 0.4% |
| Inappropriate or unexpected reset | 22 | 2.1% | 0.6% |
| Connection problema connection problem | 20 | 1.9% | 1.2% |
| No pacing | 15 | 1.4% | 0.2% |
| Battery problema problem with the battery | 13 | 1.2% | 2.2% |
| Device sensing problem | 12 | 1.2% | 0.3% |
| Failure to deliver shock/stimulation | 11 | 1.1% | 0.3% |
| Low impedance | 11 | 1.1% | 1.9% |
| Unexpected therapeutic results | 11 | 1.1% | 0.2% |
| Wireless communication problema wireless connection problem | 11 | 1.1% | 0.3% |
| Defibrillation/stimulation problem | 10 | 1% | 1.2% |
| Nonstandard device | 10 | 1% | 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 | 26 | 2.5% |
| No patient involvement | 26 | 2.5% |
| Shock from patient lead(s) | 19 | 1.8% |
| Hematomaa collection of blood under the skin or in tissue | 15 | 1.4% |
| Electric shockan electric shock | 14 | 1.3% |
| Arrhythmia | 13 | 1.2% |
| Atrial fibrillationan irregular heart rhythm | 11 | 1.1% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 11 | 1.1% |
| Shockshock, a collapse of the circulation | 10 | 1% |
| Bradycardiaslow heart rate | 9 | 0.9% |
| Bacterial infectiona bacterial infection | 8 | 0.8% |
| Dizzinesslight-headedness or unsteadiness | 7 | 0.7% |
| Tachycardiafast heart rate | 7 | 0.7% |
| Chest painchest pain | 5 | 0.5% |
| Cardiac arrestthe heart stopped | 4 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Platinium | Product code MRM | All MAUDE reports |
|---|---|---|---|
| Reports | 1,041 | 7,873 | 26,136,888 |
| Share of that pool | — | 13.2% | 0% |
| Classified as death, per 1,000 reports | 12 | 24 | 9 |
| Classified as injury | 26% | 36.1% | 36.2% |
| Classified as malfunction | 72.7% | 60% | 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 MRM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Paradym | 1,278 | 0 | 1.9% |
| Isoline | 598 | 6 | 0.8% |
| Ovatio | 675 | 0 | 3.3% |
| 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 Platinium reports
How many FDA reports name Platinium?
1,041 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 42 in the latest 12 months.
What kinds of events are reported?
malfunction (72.7%), injury (26%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
over-sensing (22.9%), inappropriate/inadequate shock/stimulation (7.7%), premature discharge of battery (7.5%), communication or transmission problem (5.9%) and failure to interrogate (5.5%). 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 Platinium 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.