LEAD MODEL 302

MDR report key: 3052431 · Received April 11, 2013

Report

Report Number: 1644487-2013-00985
Event Type: Malfunction
Date Received: April 11, 2013
Date of Event: February 27, 2013
Report Date: March 9, 2020
Manufacturer: LIVANOVA USA, INC.
Product Code: MUZ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

Additional Manufacturer Narrative · 1

DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

Description of Event or Problem · 1

REPORTER INDICATED X-RAYS OF THE PATIENT¿S VNS SHOWED A LEAD BREAK. THE VNS HAS BEEN DISABLED. THE LAST KNOWN ACCEPTABLE VNS DIAGNOSTICS RESULTS ARE UNKNOWN, AND THERE WERE NO VNS PROGRAMMING CHANGES OR OTHER CHANGES PRIOR TO THE PAINFUL STIMULATION OCCURRING.

Description of Event or Problem · 1

REPORTER INDICATED HIGH LEAD IMPEDANCE WAS OBTAINED WITH VNS SYSTEMS DIAGNOSTICS FOR A PATIENT AT AN OFFICE VISIT. THE PATIENT WAS ALSO EXPERIENCING PAINFUL STIMULATION IN THE THROAT SINCE (B)(6) 2013. THE REPORTER WAS ADVISED TO DISABLE THE VNS. NO TRAUMA OR DEVICE MANIPULATION OCCURRED. ALL ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE. SURGERY TO REPLACE THE LEAD IS LIKELY, BUT INSURANCE ISSUES ARE PREVENTING SURGERY SCHEDULING AT THIS TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT VNS WAS WORKING BUT IT HAD TO BE TURNED OFF AS IT WAS SHOCKING HER. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
156506	LEAD MODEL 302	LEAD	MUZ	LIVANOVA USA, INC.	302-20	200772

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR