SINGLE QUADRIPOLAR EXTENSION KIT Adverse Event — Malfunction (MDR 2649622-2020-08441)
SINGLE QUADRIPOLAR EXTENSION KIT Adverse Event — Malfunction (MDR 2649622-2020-08441) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SINGLE QUADRIPOLAR EXTENSION KIT; Generic name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF; Manufacturer: MPRI.
| Device | SINGLE QUADRIPOLAR EXTENSION KIT |
|---|---|
| Generic name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Manufacturer | MPRI |
| Report number | 2649622-2020-08441 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | H6. DEVICE ANALYSIS FOR EXTENSION (B)(6) REVEALED THE PACKAGING OF THE EXTENSION WAS DAMAGED. THE EXTENSION KIT WAS RECEIVED STILL IN THE SEAL TRAY. THE OUTER TRAY PACKAGING WAS CRACKED AND DAMAGED FROM ONE END. IT CANNOT BE DETERMINED HOW THE DAMAGE OCCURRED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORM |
| Source | openFDA MAUDE (device adverse events) |
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