LEAD MODEL 300

MDR report key: 1943910 · Received December 1, 2010

Report

Report Number: 1644487-2010-02704
Event Type: Malfunction
Date Received: December 1, 2010
Date of Event: October 13, 2010
Report Date: November 1, 2010
Manufacturer: CYBERONICS INC
Product Code: LYJ
PMA / PMN Number: P970003
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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 THAT THE PT HAD HIGH LEAD IMPEDANCE ON SYSTEM DIAGNOSTICS ON (B)(6) 2010. THE PT HAS ALSO HAD AN INCREASE IN SEIZURES OVER THE PAST FEW MONTHS. NO TRAUMA OR MANIPULATION WAS REPORTED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. REVISION SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LEAD MODEL 300		LYJ	CYBERONICS INC	300-20	6507

Patients

Seq	Age	Sex	Outcome	Treatment
1	18 YR		Required Intervention