MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-06-08 for WRENCH manufactured by Medtronic, Inc..
[2643579]
It was reported that during an implant attempt the atrial lead was challenging to engage the set screw and the driver dislodged twice. It was also reported that the set screw was unable to be re-engaged. A new wrench was used without difficulty and the device remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9827178]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Evaluation summary: wrench the wrench was returned, analyzed, and analysis found no anomalies. By using a sample device the wrench was able to tighten and loosen setscrews with no anomalies found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2012-01873 |
| MDR Report Key | 2606223 |
| Report Source | 05,07 |
| Date Received | 2012-06-08 |
| Date of Event | 2012-03-02 |
| Date Mfgr Received | 2012-03-02 |
| Date Added to Maude | 2012-10-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHAD HEDLUND SR VIGILANCE COMPLIANCE MGR |
| Manufacturer Street | CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635149619 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANTABLE PULSE GENERATOR ACCESSORY |
| Product Code | DTF |
| Date Received | 2012-06-08 |
| Returned To Mfg | 2012-03-22 |
| Model Number | WRENCH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4076 | 1. Other | 2012-06-08 |