AMPLIA MRI CRT-D SURESCAN Adverse Event — Malfunction (MDR 3004209178-2020-07800)
AMPLIA MRI CRT-D SURESCAN Adverse Event — Malfunction (MDR 3004209178-2020-07800) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AMPLIA MRI CRT-D SURESCAN; Generic name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD; Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS
| Device | AMPLIA MRI CRT-D SURESCAN |
|---|---|
| Generic name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Report number | 3004209178-2020-07800 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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