PACING SYSTEM ANALYZER Adverse Event — Malfunction (MDR 2182208-2020-00819)
PACING SYSTEM ANALYZER Adverse Event — Malfunction (MDR 2182208-2020-00819) 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 | 2182208-2020-00819 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | PRODUCT ANALYSIS: AT ANALYSIS IT WAS DETERMINED THAT THE CONNECTOR ON THE ANALYZER HAD CORROSION ON THE BATTERY CONTACTS AND FAILED FUNCTIONAL TESTING. THE ANALYZER WAS SENT TO THE MANUFACTURER FOR REPAIR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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