INGEVITY MRI Adverse Event — Injury (MDR 2124215-2020-09213)
INGEVITY MRI Adverse Event — Injury (MDR 2124215-2020-09213) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INGEVITY MRI; Generic name: IMPLANTABLE LEAD; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | INGEVITY MRI |
|---|---|
| Generic name | IMPLANTABLE LEAD |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2124215-2020-09213 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE HELIX WAS EXTENDED AND DRIED BLOOD/TISSUE WAS PRESENT AROUND THE HELIX. RESISTANCE TESTING FOUND THE LEAD WAS NOT ELECTRICALLY CONTINUOUS. DETAILED ANALYSIS CONFIRMED THAT THE INNER CONDUCTOR COIL HAD A BREAK AT THE DISTAL END OF THE TERMINAL PIN. BASED UPON THE CLINICAL OBSERVATIONS AND THE LABORATORY FINDIN |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →