MAUDE Adverse Event Report: MEDTRONIC, INC ZINGER GUIDE WIRE - CRDM; OCCLUDER, CATHETER TIP

Model Number LVZRMS180J

Device Problem Material Integrity Problem (2978)

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

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the guidewire was returned and analyzed.The analysis indicated that the guidewire was kinked/buckled.The guidewire was damaged and unraveled.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, placement difficulty was noted and the guidewire was stuck in the left ventricular (lv) lead.The lead was removed and replaced.No patient complications have been reported as a result of this event.

• Brand Name: ZINGER GUIDE WIRE - CRDM
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8413450
• MDR Text Key: 138564294
• Report Number: 1220452-2019-00025
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: 20643169452316
• UDI-Public: 20643169452316
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Model Number: LVZRMS180J
• Device Catalogue Number: LVZRMS180J
• Device Lot Number: G15A07079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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