PROPONENT MRI DR Adverse Event — Malfunction (MDR 2124215-2020-08784)
PROPONENT MRI DR Adverse Event — Malfunction (MDR 2124215-2020-08784) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROPONENT MRI DR; Generic name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT); Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | PROPONENT MRI DR |
|---|---|
| Generic name | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2124215-2020-08784 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED SENSING OF CHRONIC HIGH ATRIAL RATES WHICH MAY IMPACT BATTERY LONGEVITY OVER TIME. PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. |
| Source | openFDA MAUDE (device adverse events) |
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