MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-13 for UNK manufactured by Scs, Advanced Bionics.
[15028682]
Removal of electrode & generator (scs) electrode. (advanced bionics) generator. Pt has pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 843686 |
| MDR Report Key | 843686 |
| Date Received | 2007-03-13 |
| Date of Report | 2007-03-12 |
| Date of Event | 2007-01-23 |
| Date Added to Maude | 2007-05-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | ELECTRODE |
| Product Code | LHY |
| Date Received | 2007-03-13 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | * |
| Device Age | UNK |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 830888 |
| Manufacturer | SCS, ADVANCED BIONICS |
| Manufacturer Address | * * * * |
| Brand Name | UNK |
| Generic Name | GENERATOR |
| Product Code | DXY |
| Date Received | 2007-03-13 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | * |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 2 |
| Device Event Key | 830909 |
| Manufacturer | SCS, ADVANCED BIONICS |
| Manufacturer Address | * * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2007-03-13 |