MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-09 for ZINGER GUIDE WIRE - CRDM LVZRXT180S manufactured by Medtronic, Inc.
[33584279]
This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33584280]
It was reported that during an implant procedure the thin wire on the guidewire unwrapped. A new guidewire was attempted but could not be inserted into the lead. Another lead was implanted. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[42544367]
Product event summary: the guidewire was returned and analyzed. The distal conductor of the lead was obstructed due to a stylet/guidewire fragment stuck in the lumen. The stylet/guidewire was kinked/buckled. The guidewire was unraveled. Guidewire returned stuck in lead and is broken with distal coil unraveling at 2cm (from distal end of guidewire).
Patient Sequence No: 1, Text Type: N, H10
[101875239]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2015-00063 |
| MDR Report Key | 5283446 |
| Date Received | 2015-12-09 |
| Date of Report | 2015-10-28 |
| Date of Event | 2015-10-28 |
| Date Mfgr Received | 2016-02-12 |
| Device Manufacturer Date | 2014-12-30 |
| Date Added to Maude | 2015-12-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZINGER GUIDE WIRE - CRDM |
| Generic Name | OCCLUDER, CATHETER TIP |
| Product Code | DQT |
| Date Received | 2015-12-09 |
| Returned To Mfg | 2015-11-04 |
| Model Number | LVZRXT180S |
| Catalog Number | LVZRXT180S |
| Lot Number | G14A08936 |
| Device Expiration Date | 2017-12-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC |
| Manufacturer Address | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-09 |