MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-02-14 for DBS BURRHOLE CAP NA manufactured by Medtronic Inc..
[17515967]
Device returned with report of "pt's body rejected cap". Follow up with hcp revealed 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. Tissue excised and sent for pathology exam revealed foreign body reaction. 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 | 2182207-2001-00097 |
| MDR Report Key | 376983 |
| Report Source | 05 |
| Date Received | 2002-02-14 |
| Date of Event | 2001-11-02 |
| Date Added to Maude | 2002-02-20 |
| 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 | 2002-02-14 |
| Returned To Mfg | 2001-02-22 |
| Model Number | BURRHOLE CAP |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 366063 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 800 53RD AVE., N.E. 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; 2. Other | 2002-02-14 |