MAUDE Adverse Event Report: MEDTRONIC, INC ZINGER GUIDE WIRE - CRDM; OCCLUDER, CATHETER TIP

Model Number	LVZRMS180J
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure, the guidewire unraveled when being removed from the left ventricular lead after it was placed into vein.The physician cut the wire at the proximal end of the lead, removed the lead and was able to extract the remaining portion of the wire from inside the lead.The lead was evaluated and determined to be undamaged and was re-implanted using a different guidewire.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the guidewire was returned in segments, and analyzed.Analysis indicated that the guidewire was unraveled.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZINGER GUIDE WIRE - CRDM
• Common Device Name: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8043166
• Report Number: 1220452-2018-00131
• Device Sequence Number: 16488846
• Product Code: DQT
• UDI-Device Identifier: 00643169452312
• UDI-Public: 00643169452312
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K983927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2021
• Device Model Number: LVZRMS180J
• Device Catalogue Number: LVZRMS180J
• Device Lot Number: G18A08016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 03/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR