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

Model Number	LVZRMS180S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
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 of the left ventricular lead, the guidewire was destroyed and it could not be pulled out from the lead.The lead was not implanted.The guidewire subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.

• Brand Name: ZINGER MEDIUM
• Common Device Name: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8387013
• Report Number: 1220452-2019-00019
• Device Sequence Number: 16701175
• Product Code: DQT
• UDI-Device Identifier: 20643169452309
• UDI-Public: 20643169452309
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K983927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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: 08/25/2018
• Device Model Number: LVZRMS180S
• Device Catalogue Number: LVZRMS180S
• Device Lot Number: G15A07658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR