MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-14 for ZINGER GUIDE WIRE - CRDM LVZRXT180J manufactured by Medtronic, Inc.
[117146164]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117146165]
It was reported that during the implant procedure, the guidewire broke. The guidewire was replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220452-2018-00103 |
| MDR Report Key | 7781335 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-07-25 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-08-14 |
| 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, INC |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| 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 | 2018-08-14 |
| Returned To Mfg | 2018-08-10 |
| Model Number | LVZRXT180J |
| Catalog Number | LVZRXT180J |
| Lot Number | G18A01217 |
| 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 | 2018-08-14 |