CARELINK PROGRAMMER Adverse Event — Malfunction (MDR 2182208-2020-00822)
CARELINK PROGRAMMER Adverse Event — Malfunction (MDR 2182208-2020-00822) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CARELINK PROGRAMMER; Generic name: PROGRAMMER, PACEMAKER; Manufacturer: MEDTRONIC, INC..
| Device | CARELINK PROGRAMMER |
|---|---|
| Generic name | PROGRAMMER, PACEMAKER |
| Manufacturer | MEDTRONIC, INC. |
| Report number | 2182208-2020-00822 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THAT THE PROGRAMMER WOULD NOT POWER UP NOTING THAT THE PROGRAMMER POWERED UP AS NORMAL. ANALYSIS WAS ABLE TO CONFIRM THAT THE CURSOR AND THE STYLUS WERE MISALIGNED. ANALYSIS ALSO FOUND THAT A SCREW FROM THE XY BOARD FELL OUT AND WAS RATTLING IN THE DISPLAY AREA, THE STYLUS WAS MISSING, AND THE HANDLE COVERS WERE CRACKED. ALL FOUND DEFECTIVE PARTS WE |
| Source | openFDA MAUDE (device adverse events) |
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