INGEVITY MRI Adverse Event — Injury (MDR 2124215-2020-09305)
INGEVITY MRI Adverse Event — Injury (MDR 2124215-2020-09305) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INGEVITY MRI; Generic name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | INGEVITY MRI |
|---|---|
| Generic name | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2124215-2020-09305 |
| Event type | Injury |
| 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. OBJECTIVE EVIDENCE FROM FIELD DETERMINED THAT PERFORATION OCCURRED. PERFORATION IS A KNOWN POSSIBLE COMPLICATION OF AN IMPLANTABLE LEAD. |
| Source | openFDA MAUDE (device adverse events) |
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