CARELINK PROGRAMMER Adverse Event — Malfunction (MDR 2182208-2020-00823)
CARELINK PROGRAMMER Adverse Event — Malfunction (MDR 2182208-2020-00823) 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 | 2182208-2020-00823 |
| 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 WOULD NOT FOLLOW THE STYLUS NOTING THAT THE XY BOARD WAS OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THAT THE LOWER CASE WAS CRACKED. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WER |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →