FDA Adverse Event Malfunction Summary report: N

BIPOLAR LEAD MODEL 300

MDR report key: 1052422 · Received May 21, 2008

Report

Report Number: 1644487-2008-01194
Event Type: Malfunction
Date Received: May 21, 2008
Date of Event: January 1, 2008
Report Date: April 25, 2008
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

Description of Event or Problem · 1

IT WAS REPORTED TO MANUFACTURER THAT HIGH LEAD IMPEDANCE RESULTED FROM BOTH A SYSTEM AND NORMAL MODE TEST WHEN THE VNS PATIENT'S DEVICE WAS TESTED AT A FOLLOW UP VISIT. THERE WAS NO REPORT OF TRAUMA OR MANIPULATION THAT COULD HAVE CONTRIBUTED TO THE HIGH LEAD IMPEDANCE, HOWEVER THE PHYSICIAN DID STATE THAT THE PATIENT DOES HAVE MANY SEIZURES AND FALLS OFTEN. THE DEVICE WAS SUBSEQUENTLY DISABLED. ADDITIONALLY, IT WAS REPORTED THAT THE VNS PATIENT HAD EXPERIENCED A RECENT INCREASE IN SEIZURE ACTIVITY, RETURN TO PRE-VNS BASELINE. THE LAST GOOD DIAGNOSTIC TEST RESULTS WERE RECEIVED ABOUT A YEAR AGO ACCORDING TO THE PHYSICIAN. X-RAYS WERE TAKEN AND SENT TO MANUFACTURER TO REVIEW. THE LEAD BODY WAS VISIBLE AND NO GROSS LEAD FRACTURE WAS FOUND. A PORTION OF THE LEAD COULD NOT BE ASSESSED BECAUSE IT WAS LOCATED BEHIND THE GENERATOR. THERE WERE NO OBVIOUS ANOMALIES VISUALIZED ON THE X-RAYS. THE PATIENT WAS SEEN FOR A SURGICAL CONSULT AND REVISION SURGERY IS LIKELY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BIPOLAR LEAD MODEL 300		LYJ	CYBERONICS, INC.	300-20	193323C

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR