MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-10-13 for NONE 5873W manufactured by Medtronic, Inc..
[18509061]
It was reported that while the physician was attempting to place the lead into the competitor device five wrenches broke while tightening and untightening the setscrew. It was noted that the metal came out of the wrenches. It was also reported that the lead had increasing impedance. The lead remains in use. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[18740109]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2011-02213 |
| MDR Report Key | 2291023 |
| Report Source | 05,07 |
| Date Received | 2011-10-13 |
| Date Mfgr Received | 2011-07-29 |
| Device Manufacturer Date | 2011-05-05 |
| Date Added to Maude | 2011-10-13 |
| 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 |
| Removal Correction Number | ASKU |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | LEAD SERVICE KIT |
| Product Code | KFJ |
| Date Received | 2011-10-13 |
| Model Number | 5873W |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 6949 | 1. Other | 2011-10-13 |