MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-04-10 for 5873W manufactured by Medtronic, Inc..
[2593361]
It was reported that at the device implant attempt a wrench tool broke in the device header. The device was not used and was replaced. It was further reported that two additional ratchet wrenches broke during the device changeout procedure. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9947828]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Evaluation summary: (b)(4), the device was returned and analyzed. No anomalies were found. Foreign material was noted in the set screw. The (b)(4) and ratchet wrenches were broken. The analyst noted a piece of broken wrench in the ventricular setscrew.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2012-01170 |
| MDR Report Key | 2525548 |
| Report Source | 05,07 |
| Date Received | 2012-04-10 |
| Date of Event | 2011-03-23 |
| Date Mfgr Received | 2011-03-23 |
| Device Manufacturer Date | 2010-12-22 |
| Date Added to Maude | 2012-04-10 |
| 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 | LEAD SERVICE KIT |
| Product Code | KFJ |
| Date Received | 2012-04-10 |
| Returned To Mfg | 2011-03-29 |
| Model Number | 5873W |
| 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 | 0 | 1. Other | 2012-04-10 |