MAUDE Adverse Event Report: MEDTRONIC, INC ZINGER XT; OCCLUDER, CATHETER TIP

Model Number	LVZRXT180J
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
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 attempt, the guidewire broke off while in the lead.The lead was implanted with a half inch of the wire fragment hanging out of the distal end of the lead.The lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: ZINGER XT
• Common Device Name: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9205471
• Report Number: 1220452-2019-00136
• Device Sequence Number: 10874539
• Product Code: DQT
• UDI-Device Identifier: 00643169452299
• UDI-Public: 00643169452299
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 10/17/2019

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: 10/24/2021
• Device Model Number: LVZRXT180J
• Device Catalogue Number: LVZRXT180J
• Device Lot Number: G18A10971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR