EVERA MRI XT DR SURESCAN Adverse Event — Malfunction (MDR 9614453-2020-01363)
EVERA MRI XT DR SURESCAN Adverse Event — Malfunction (MDR 9614453-2020-01363) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EVERA MRI XT DR SURESCAN; Generic name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER; Manufacturer: MEDTRONIC EUROPE SARL.
| Device | EVERA MRI XT DR SURESCAN |
|---|---|
| Generic name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER |
| Manufacturer | MEDTRONIC EUROPE SARL |
| Report number | 9614453-2020-01363 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY HAD AN OBSERVATION RELATING TO THE BATTERY LONGEVITY ESTIMATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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