MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-08-21 for DBS 3389 NA manufactured by Medtronic Inc..
[17174823]
The pt underwent implantation of a neurostimulation system for tremor related to parkinson's disease. During the implant procedure, the lead was placed too deep and the hcp repositioned the lead. The hcp noted the pt had postoperative speech and swallowing difficulties, which improved postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2001-00271 |
| MDR Report Key | 348689 |
| Report Source | 05 |
| Date Received | 2001-08-21 |
| Date of Report | 2001-08-17 |
| Date Mfgr Received | 2001-08-17 |
| Date Added to Maude | 2001-08-28 |
| 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 | LEAD |
| Product Code | GYZ |
| Date Received | 2001-08-21 |
| Model Number | 3389 |
| Catalog Number | NA |
| Lot Number | J0104134V |
| ID Number | NA |
| Device Expiration Date | 2005-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 338005 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | IMPLANTABLE LEAD FOR BRAIN STIMULATION |
| Baseline Model No | 3389 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-08-21 |