MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-11 for LEAD WRENCH * manufactured by Medtronic, Inc..
[16109913]
The metal end of the medtronic wrench sheared off when the doctor was attempting to unscrew a lead from the device. The sheared end of the wrench was retrieved. A new wrench was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 839570 |
| MDR Report Key | 839570 |
| Date Received | 2007-04-11 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-20 |
| Report Date | 2007-04-11 |
| Date Reported to FDA | 2007-04-11 |
| Date Added to Maude | 2007-04-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD WRENCH |
| Generic Name | WRENCH, PULSE GENERATOR LEAD |
| Product Code | DTF |
| Date Received | 2007-04-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 826858 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | CARDIAC RHYTHM MANAGEMENT 7000 CENTRAL AVE, NE; CW 304 ( MINNEAPOLIS MN 55432 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-11 |