MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-01-29 for DBS 3389 NA manufactured by Medtronic Inc..
| Report Number | 2182207-2002-00065 |
| MDR Report Key | 374574 |
| Report Source | 05,06 |
| Date Received | 2002-01-29 |
| Date of Report | 2002-01-23 |
| Date of Event | 2001-12-10 |
| Date Mfgr Received | 2002-01-23 |
| Date Added to Maude | 2002-02-01 |
| 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 | 2002-01-29 |
| Model Number | 3389 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | * |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 363704 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 800 53RD AVE., N.E. P.O. BOX 1250 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 | 2002-01-29 |