Devices › Permanent defibrillator electrodes
Device brand name · Icd lead
Plexa ProMRI S 65: medical device reports filed with FDA
2,521 reports name it, 2017–2026. Manufacturer given most often on reports: Biotronik Se & Kg. Product code NVY.
- 2,521
- device reports naming the brand
- 0% of all MAUDE reports · about 270 a year
- 245
- reports, 12 months to August 2026
- 323 in the 12 months before
- 58.8%
- classified as malfunction
- 41.2% across the product code
- 0.6%
- classified as death, as reported
- 14 reports · not verified by FDA
FDA's MAUDE database holds 2,521 reports that name the brand "Plexa ProMRI S 65" (icd lead), received between March 2017 and August 2026; the manufacturer given most often on reports is Biotronik Se & Kg. Spellings of one product vary from report to report.
245 reports arrived in the 12 months to August 2026, down 24% from 323 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 (58.8%), injury (40.7%) and death (0.6%); across all permanent defibrillator electrodes reports (product code NVY) death is recorded in 2.2% 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 over-sensing (28.9%), ambient noise problem (22.1%) and inappropriate/inadequate shock/stimulation (15.4%). The patient problems coded most often are shock from patient lead(s), cardiac perforation and pocket erosion. 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 138,578 reports carrying product code NVY. 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 | 729 | 28.9% | 22.8% |
| Ambient noise problem | 557 | 22.1% | 3.7% |
| Inappropriate/inadequate shock/stimulation | 389 | 15.4% | 8.5% |
| Device dislodged or dislocated | 232 | 9.2% | 10.9% |
| High impedance | 205 | 8.1% | 20% |
| Fracturea broken bone | 171 | 6.8% | 5.4% |
| High capture threshold | 112 | 4.4% | 8.1% |
| Impedance problem | 93 | 3.7% | 3.1% |
| Device sensing problem | 85 | 3.4% | 5% |
| Failure to capture | 79 | 3.1% | 8.1% |
| Low impedance | 59 | 2.3% | 6% |
| Breakthe device broke | 57 | 2.3% | 8.8% |
| Under-sensing | 54 | 2.1% | 2.5% |
| Insufficient device problem information | 25 | 1% | 2.1% |
| Signal artifact/noise | 21 | 0.8% | 6.6% |
| Unstable capture threshold | 18 | 0.7% | 0.2% |
| Pacing intermittently | 10 | 0.4% | 0% |
| Failure to convert rhythm | 7 | 0.3% | 0.5% |
| Failure to sense | 7 | 0.3% | 0.9% |
| Defibrillation/stimulation problem | 6 | 0.2% | 0.4% |
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 |
|---|---|---|
| Shock from patient lead(s) | 392 | 15.5% |
| Cardiac perforation | 31 | 1.2% |
| Pocket erosion | 25 | 1% |
| Twiddlers syndrome | 20 | 0.8% |
| Endocarditis | 14 | 0.6% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 13 | 0.5% |
| Hematomaa collection of blood under the skin or in tissue | 11 | 0.4% |
| Perforation | 9 | 0.4% |
| Sepsisa severe body-wide response to infection | 7 | 0.3% |
| Bacteremia | 6 | 0.2% |
| Falla fall | 6 | 0.2% |
| Tachycardiafast heart rate | 6 | 0.2% |
| Cardiac tamponade | 5 | 0.2% |
| Bacterial infectiona bacterial infection | 4 | 0.2% |
| Discomfortdiscomfort | 4 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Plexa ProMRI S 65 | Product code NVY | All MAUDE reports |
|---|---|---|---|
| Reports | 2,521 | 138,578 | 26,136,888 |
| Share of that pool | — | 1.8% | 0% |
| Classified as death, per 1,000 reports | 6 | 22 | 9 |
| Classified as injury | 40.7% | 56.5% | 36.2% |
| Classified as malfunction | 58.8% | 41.2% | 62.3% |
| Filed by the manufacturer | 99.9% | 97.3% | 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 NVY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Durata Sts Optim Active Fixation Df-4 Connector | 27,828 | 1,784 | 3.9% |
| Endotak Reliance | 25,897 | 238 | 1.2% |
| Riata Active Fixation | 13,753 | 96 | 1.8% |
| Sprint Quattro Secure MRI SureScan | 15,606 | 1,903 | 1.4% |
| Optisure Active Fixation Df-4 Connector | 6,562 | 623 | 4.3% |
| Endotak Reliance Sg | 8,288 | 1,083 | 0.5% |
| Sprint Quattro Secure | 24,237 | 2 | 5.2% |
| Riata St Active Fixation | 5,416 | 76 | 2.2% |
| Reliance 4-Front | 9,852 | 2,024 | 0.4% |
| Isoflex Optim Lead | 7,889 | 437 | 2% |
| Durata Sts Optim Active Fixation | 9,681 | 301 | 5.6% |
| Riata Passive Fixation | 4,318 | 32 | 1.2% |
| Endotak Reliance G | 10,115 | 1,049 | 0.6% |
| Permanent Defibrillator Electrodes | 2,524 | 230 | 0.6% |
| Epsila EV MRI SureScan | 1,869 | 1,023 | 1% |
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 Plexa ProMRI S 65 reports
How many FDA reports name Plexa ProMRI S 65?
2,521 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 245 in the latest 12 months.
What kinds of events are reported?
malfunction (58.8%), injury (40.7%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
over-sensing (28.9%), ambient noise problem (22.1%), inappropriate/inadequate shock/stimulation (15.4%), device dislodged or dislocated (9.2%) and high impedance (8.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary 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 Plexa ProMRI S 65 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.