PACING SYSTEM ANALYZER Adverse Event — Malfunction (MDR 2182208-2020-00826)
PACING SYSTEM ANALYZER Adverse Event — Malfunction (MDR 2182208-2020-00826) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PACING SYSTEM ANALYZER; Generic name: PROGRAMMER, PACEMAKER; Manufacturer: MEDTRONIC, INC..
| Device | PACING SYSTEM ANALYZER |
|---|---|
| Generic name | PROGRAMMER, PACEMAKER |
| Manufacturer | MEDTRONIC, INC. |
| Report number | 2182208-2020-00826 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT ANALYSIS: ANALYSIS FOUND THAT THE ANALYZER FAILED INCOMING TESTS. THE ANALYZER WAS REPLACED AND WILL BE REPAIRED AND ADDED TO THE REPLACEMENT POOL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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