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	04/15/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8656042
• Report Number: 1220452-2019-00071
• Device Sequence Number: 2473172
• Product Code: DQT
• UDI-Device Identifier: 00643169452299
• UDI-Public: 00643169452299
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR