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

Model Number	LVZRLS180J
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed.The analysis indicated that the stylet/guidewire was broken.The guidewire was unraveled.Visual analysis of the guidewire indicated damage during use.The analyst noted a partial guidewire was returned without the distal end of the guidewire in a dispenser.The distal end of the guidewire was not returned.The distal end of the guidewire is unraveled and broken.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure the guidewire broke while being removed from the lead.The rest of the guidewire was removed from the lead and a new guidewire was used to successfully place the lead.The guidewire was returned to the manufacturer, analyzed and it was determined that the guidewire had broken and unraveled.No patient complications have been reported as a result of this event.

• Brand Name: ZINGER LIGHT
• Common Device Name: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9377787
• Report Number: 1220452-2019-00151
• Device Sequence Number: 3077709
• Product Code: DQT
• UDI-Device Identifier: 00643169452336
• UDI-Public: 00643169452336
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K983927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: 09/11/2021
• Device Model Number: LVZRLS180J
• Device Catalogue Number: LVZRLS180J
• Device Lot Number: G18A09565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 118