SPRINT QUATTRO SECURE S MRI SURESCAN Adverse Event — Injury (MDR 2649622-2020-08430)
SPRINT QUATTRO SECURE S MRI SURESCAN Adverse Event — Injury (MDR 2649622-2020-08430) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SPRINT QUATTRO SECURE S MRI SURESCAN; Generic name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER; Manufacturer: MPRI.
| Device | SPRINT QUATTRO SECURE S MRI SURESCAN |
|---|---|
| Generic name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER |
| Manufacturer | MPRI |
| Report number | 2649622-2020-08430 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANC |
| Source | openFDA MAUDE (device adverse events) |
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