FDA Adverse Event Malfunction Summary report: N

BIPOL LEAD MODEL 302

MDR report key: 1831834 · Received September 8, 2010

Report

Report Number: 1644487-2010-02046
Event Type: Malfunction
Date Received: September 8, 2010
Date of Event: August 2, 2010
Report Date: August 9, 2010
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: NURSE
Health Professional: N

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

IT WAS INITIALLY REPORTED THAT DURING RECENTLY PERFORMED DIAGNOSTICS, HIGH LEAD IMPEDANCE WAS OBSERVED. THE PATIENT WAS SAID TO HISTORICALLY HAVE DIAGNOSTICS WITHIN NORMAL LIMITS. THE PATIENT WAS SAID TO HAVE HAD NO FALLS AND IS AT PRESENTLY SEIZURE-FREE. X-RAYS WERE TAKEN AND IMAGES WERE EMAILED TO MANUFACTURER FOR REVIEW. BASED ON THE X-RAY IMAGE RECEIVED THERE WAS NO ANOMALY VISUALIZED THAT COULD HAVE BEEN CONTRIBUTING TO THE HIGH LEAD IMPEDANCE REPORTED. DUE TO THE LIMITED IMAGES AVAILABLE AND POOR IMAGE QUALITY, THE LEAD BODY COULD NOT BE COMPLETELY ASSESSED. A SEARCH PERFORMED IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE DID NOT PROVIDE ANY DIAGNOSTIC HISTORY FOR PATIENT'S DEVICE. AT THIS TIME THERE IS NO DECISION KNOWN ABOUT THE REFERRAL FOR REVISION SURGERY. X-RAYS IMAGES HAVE BEEN REQUESTED FOR ADDITIONAL REVIEW. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BIPOL LEAD MODEL 302		LYJ	CYBERONICS, INC.	302-20	1008

Patients

Seq	Age	Sex	Outcome	Treatment
1	36 YR	Male