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 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the guidewire was returned and analyzed.The guidewire was unraveled.The distal conductor of the lead was obstructed due to a guidewire stuck in the lumen.Visual analysis of the guidewire indicated damage during use.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during left ventricular (lv) lead implant the guidewire got stuck after being placed and maneuvered inside the lead, making it hardly removable.The lead was removed and a new lead was implanted.The guidewire was returned, analyzed, and tested out of specification.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: 8656042
• MDR Text Key: 146639276
• Report Number: 1220452-2019-00071
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 83 YR