MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2001-11-09 for DBS BURRHOLE CAP NA manufactured by Medtronic Inc..
[237643]
Hcp reported having a pt with inflammatory response at the burr hole cap. Hcp is concerned there is a problem with the cap. The area was not infected but appeared to be "some type of adverse reaction to material or something in the area". Pt had a small amount of yellow clear (serous) drainage but no signs of infection. Cap and ring removed and returned for analysis. Cap and ring replaced with a metal plating system, the pt is doing better and the wound healing nicely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2001-00419 |
| MDR Report Key | 360904 |
| Report Source | 05,07 |
| Date Received | 2001-11-09 |
| Date of Report | 2001-04-03 |
| Date Mfgr Received | 2001-04-03 |
| Date Added to Maude | 2001-11-26 |
| 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 |
| Manufacturer Contact | VICKI SCHREIBER |
| Manufacturer Street | 800 53RD AVE. NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal | 55421 |
| Manufacturer Phone | 7635147316 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBS |
| Generic Name | STIM ACCESSORY |
| Product Code | GYZ |
| Date Received | 2001-11-09 |
| Returned To Mfg | 2001-04-03 |
| Model Number | BURRHOLE CAP |
| Catalog Number | NA |
| Lot Number | J0101900V |
| ID Number | NA |
| Device Expiration Date | 2005-01-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 350062 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | STIM ACCESSORY |
| Baseline Model No | BURRHOLE CAP |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-11-09 |