SPRINT QUATTRO Adverse Event — Injury (MDR 2649622-2020-08345)
SPRINT QUATTRO Adverse Event — Injury (MDR 2649622-2020-08345) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SPRINT QUATTRO; Generic name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER; Manufacturer: MPRI.
| Device | SPRINT QUATTRO |
|---|---|
| Generic name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER |
| Manufacturer | MPRI |
| Report number | 2649622-2020-08345 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT ANALYSIS: 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 DUE TO NON-PHYSIOLOGIC SIGNALS/SENSING INTEGRITY COUNTER. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ANALYSIS OF THE DEVICE MEMORY INDICATED THE |
| Source | openFDA MAUDE (device adverse events) |
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