SELECTSECURE MRI SURESCAN Adverse Event — Injury (MDR 2649622-2020-08359)
SELECTSECURE MRI SURESCAN Adverse Event — Injury (MDR 2649622-2020-08359) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SELECTSECURE MRI SURESCAN; Generic name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIA; Manufacturer: MPRI.
| Device | SELECTSECURE MRI SURESCAN |
|---|---|
| Generic name | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIA |
| Manufacturer | MPRI |
| Report number | 2649622-2020-08359 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE |
| Source | openFDA MAUDE (device adverse events) |
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