MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2015-08-04 for ZINGER GUIDE WIRE - CRDM LVZRXT180S manufactured by Medtronic, Inc.
[20035626]
After left ventricular lead implantation , the guidewire was fixed in the lead. After some rotation and heavy pulling, a part of the guidewire came out of the lead. After that a small thin part of the guidewire stayed in the lead. It was extracted out of the lead. After x ray, a small part of the guidewire stayed deep in the vessel next to the lead. It was not possible to extract that small part of the wire. It was not possible to get it out of the patient. No additional patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[20286255]
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
[39226709]
Product event summary: received was a tangle of coil wire from a guide wire. Tangle of coil wire is likely from the complaint wire. The section of coil wire received has no tip attached. This portion of wire is consistent with the reported event. ? A small thin part of wire that was extracted out of the lead.? This is all that was received for analysis.
Patient Sequence No: 1, Text Type: N, H10
[100789545]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2015-00036 |
| MDR Report Key | 4967993 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2015-08-04 |
| Date of Report | 2015-06-05 |
| Date of Event | 2015-06-05 |
| Date Mfgr Received | 2015-11-06 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-08-05 |
| 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 | 2015-08-04 |
| Returned To Mfg | 2015-06-23 |
| Model Number | LVZRXT180S |
| Catalog Number | LVZRXT180S |
| Lot Number | G14A07220 |
| Device Expiration Date | 2017-11-30 |
| 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 | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-08-04 |