LEAD MODEL 302

MDR report key: 2363617 · Received November 17, 2011

Report

Report Number: 1644487-2011-02771
Event Type: Malfunction
Date Received: November 17, 2011
Date of Event: November 1, 2011
Report Date: November 1, 2011
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS OBSERVED DURING A PT'S DIAGNOSTIC TEST. THE PHYSICIAN NOTED THAT THE PT WAS AT THE PLAYGROUND SKATING AND FELL SEVERAL TIMES, SO IT IS LIKELY THAT THIS TRAUMA MAY HAVE CAUSED THE HIGH IMPEDANCE. THE PT HAD FULL VNS REPLACEMENT SURGERY. THE GENERATOR WAS REPLACED PROPHYLACTICALLY, AND THE LEAD WAS REPLACED DUE TO THE HIGH IMPEDANCE. THE MANUFACTURER'S CONSULTANT REPORTED AFTER THE SURGERY THAT THE PT BROKE HIS LEAD ROLLER-SKATING AND THE LEAD WAS VISIBLY FRACTURED. THE GENERATOR, WHICH WAS IMPLANTED ON (B)(6) 2011, WAS REPLACED PROPHYLACTICALLY BECAUSE THE PT'S PREVIOUS GENERATOR LASTED TWO YEARS DUE TO HIS HIGH PROGRAMMING SETTINGS, SO THE PHYSICIAN DECIDED TO REPLACE THE BATTERY IN ADDITION TO THE LEAD WHILE THE PT WAS IN SURGERY. ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE. UPON COMPLETION OF THE SURGERY, IT WAS REPORTED THAT SYSTEMS DIAGNOSTICS WERE PERFORMED AND ALL RESULTS WERE OKAY. THE GENERATOR LEAD WERE RECEIVED BY THE MFR, BUT PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LEAD MODEL 302		LYJ	CYBERONICS, INC.	302-20	2329

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR