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 2014-04-11 for ZINGER MEDIUM LVZRMS180S manufactured by Medtronic, Inc.
[4222986]
It was reported that while repositioning the left ventricular (lv) lead under x-ray due to a dislodgement, upon pulling the guidewire out of the lv lead, the guidewire broke. The lv lead was explanted with most of the guidewire included, however, one segment of the wire remained inside the patient's atrium. The lv lead was replaced successfully. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11792059]
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
[22225926]
Product event summary: the guidewire was returned, analyzed and the stylet/guidewire was broken and damaged. The guidewire was unraveled. Visual summary analysis of the lead indicated damage at implant.
Patient Sequence No: 1, Text Type: N, H10
[100788361]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2014-00019 |
| MDR Report Key | 3745252 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2014-04-11 |
| Date of Report | 2014-02-24 |
| Date of Event | 2014-02-24 |
| Date Mfgr Received | 2014-12-10 |
| Device Manufacturer Date | 2012-12-03 |
| Date Added to Maude | 2014-04-14 |
| 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 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 MEDIUM |
| Generic Name | OCCLUDER, CATHETER TIP |
| Product Code | DQT |
| Date Received | 2014-04-11 |
| Returned To Mfg | 2014-03-06 |
| Model Number | LVZRMS180S |
| Catalog Number | LVZRMS180S |
| Lot Number | GR577 |
| Device Expiration Date | 2015-12-03 |
| 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 | 419488 | 1. Required No Informationntervention | 2014-04-11 |