INGEVITY MRI Adverse Event — Injury (MDR 2124215-2020-09202)
INGEVITY MRI Adverse Event — Injury (MDR 2124215-2020-09202) 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 | 2124215-2020-09202 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL EXAMINATION CONFIRMED THE COMPLETE LEAD WAS RETURNED, SEVERED IN TWO SEGMENTS. EXAMINATION ALSO NOTED THE HELIX MECHANISM WAS RETRACTED AND DRIED BLOOD WAS PRESENT IN THE HELIX HOUSING. RESISTANCE TESTING CONFIRMED THE TWO SEGMENTS WERE ELECTRICALLY CONTINUOUS. AN X-RAY OF EACH LEAD SEGMENT NOTED A SLIGHTLY STRETCHED CATHODE INNE |
| Source | openFDA MAUDE (device adverse events) |
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