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

Model Number	LVZRMS180J
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed.The analysis indicated that the guidewire was damaged.The guidewire was kinked/buckled.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.
Event or Problem Description
It was reported that during implant, the guidewire became stuck inside the lead and was unable to be retracted.The physician removed both the lead and guidewire and implant was attempted with a new lead as well as a new guidewire.During implant of the replacement lead, the new guidewire again became stuck in the lead, however the guidewire was eventually able to be retracted.No patient complications have been reported as a result of this event.

• 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: 8412741
• Report Number: 1220452-2019-00022
• Device Sequence Number: 239482
• Product Code: DQT
• UDI-Device Identifier: 20643169452316
• UDI-Public: 20643169452316
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K983927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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: 06/03/2018
• Device Model Number: LVZRMS180J
• Device Catalogue Number: LVZRMS180J
• Device Lot Number: G15A05727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1