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

Model Number LVZRXT180J

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9205471
• MDR Text Key: 163636480
• Report Number: 1220452-2019-00136
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: 00643169452299
• UDI-Public: 00643169452299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2019
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR