MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-05 for INTELECT/LEGEND COMBO 4C * manufactured by Chattanooga Group.
[17822743]
After session of e-stim [electrical stimulation], pt reported pain under one electrode. There was only redness noted after the session. In 2003, pt came in with complaint of burn [extent of burn unk] and sore on left upper trap [trapezius muscle].
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 509878 |
| MDR Report Key | 509878 |
| Date Received | 2004-02-05 |
| Date of Report | 2003-11-01 |
| Date of Event | 2003-10-01 |
| Date Added to Maude | 2004-02-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | INTELECT/LEGEND COMBO |
| Generic Name | STIMULATOR |
| Product Code | BXM |
| Date Received | 2004-02-05 |
| Model Number | 4C |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 498847 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS RD HIXSON TN 37343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-05 |