MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-12-10 for DBS 3387 NA manufactured by Medtronic Inc...
[16367005]
Hcp reported "broken lead seen on x-ray; shocks in arm". The device was explanted but not returned to the mfr for analysis. A f/u report will be sent when add'l info is rec'd.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2001-00701 |
| MDR Report Key | 366206 |
| Report Source | 05 |
| Date Received | 2001-12-10 |
| Date of Report | 2001-04-11 |
| Date of Event | 2001-03-12 |
| Date Mfgr Received | 2001-04-11 |
| Date Added to Maude | 2001-12-19 |
| 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 | 2001-12-10 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | L67133 |
| ID Number | NA |
| Device Expiration Date | 2003-07-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 355329 |
| Manufacturer | MEDTRONIC INC.. |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | LEAD FOR BRAIN STIMULATION |
| Baseline Model No | 3387 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | STIM DBS LEAD |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9600 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-12-10 |