MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-06-10 for ZINGER GUIDE WIRE - CRDM LVZRXT180J manufactured by Medtronic, Inc..
[5935441]
It was reported that during the implant the guide wire was damaged and stretched so the left ventricular (lv) lead and the guide wire were removed and replaced for reported dislodgement and/or placement difficulty. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[13460352]
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
[23190049]
Product event summary: the device was returned and analyzed. Analysis revealed the stylet/guidewire was kinked/buckled. There was blood on the stylet/guidewire, and the guidewire was unraveled. Visual summary analysis of the lead indicated damage at implant.
Patient Sequence No: 1, Text Type: N, H10
[42985353]
.
Patient Sequence No: 1, Text Type: N, H10
[99264010]
Corrected information no eval explain. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2015-01981 |
| MDR Report Key | 4833945 |
| Report Source | 01,05,07 |
| Date Received | 2015-06-10 |
| Date of Report | 2015-04-13 |
| Date of Event | 2015-04-13 |
| Date Mfgr Received | 2016-01-15 |
| Date Added to Maude | 2015-07-09 |
| 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 | 2015-06-10 |
| Returned To Mfg | 2015-05-20 |
| Model Number | LVZRXT180J |
| Catalog Number | LVZRXT180J |
| Lot Number | G14A05208 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-10 |