MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 1996-10-15 for NS252 INNERVATOR * manufactured by Fisher & Paykel Electronics Ltd.
[22951]
Device in use on ulnar nerve set at 80ma all the time during procedures. Observed that pt was burned at the site of the electrodes, one site leaving two black dots, the other site a small blister. Unit taken out of service and found to be operating correctly by biomedical engineering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-1996-00001 |
| MDR Report Key | 43687 |
| Report Source | 05,06,08 |
| Date Received | 1996-10-15 |
| Date of Report | 1996-10-09 |
| Date of Event | 1996-09-11 |
| Date Mfgr Received | 1996-09-11 |
| Date Added to Maude | 1996-10-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NS252 INNERVATOR |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | BXN |
| Date Received | 1996-10-15 |
| Model Number | NS252 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 44642 |
| Manufacturer | FISHER & PAYKEL ELECTRONICS LTD |
| Manufacturer Address | 25 CARBINE ROAD PO BOX 14-348 PANMURE AUCKLAND NZ |
| Baseline Brand Name | INNERVATOR NS252 |
| Baseline Generic Name | PERIPHERAL NERVE STIMULATOR |
| Baseline Model No | NS252 |
| Baseline Catalog No | NS252 |
| Baseline ID | * |
| Baseline Device Family | CONSTANT CURRENT PERIPHERAL NERVE STIMULATORS |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K882438 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-15 |