FDA Adverse Event Injury Summary report: N

PULSE GEN MODEL 102

MDR report key: 1830964 · Received September 7, 2010

Report

Report Number: 1644487-2010-02032
Event Type: Injury
Date Received: September 7, 2010
Date of Event: June 18, 2010
Report Date: August 26, 2010
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THROUGH CLINIC NOTES THAT A VNS PATIENT EXPERIENCED AN INCREASE IN SEIZURES DUE TO KNOWN REASON. FOLLOW-UP WITH THE PATIENT'S TREATING NURSE REVEALED THE PATIENT'S INCREASE IN SEIZURES WAS DUE TO LONGEVITY OF THE DEVICE. MOREOVER, THE PRE-VNS BASELINE FOR THE INCREASE WAS NOT KNOWN BY THE NURSE AND NO MEDICATION OR PROGRAMMING CHANGES SEEMED TO HAVE PRE-VNS BASELINE FOR THE INCREASE WAS NOT KNOWN BY THE NURSE AND NO MEDICATION OR PROGRAMMING CHANGES SEEMED TO HAVE CONTRIBUTED TO THE INCREASE. A BATTERY LIFE CALCULATION WAS PROVIDED TO THE TREATING PHYSICIAN INDICATING .84 YEARS UNTIL EOS=YES. MOREOVER, THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY, AND IT WAS NOTED THE REASON FOR REPLACEMENT WAS DUE TO BATTERY DEPLETION. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER AND UNDERWENT PRODUCT ANALYSIS. PRODUCT ANALYSIS OF THE GENERATOR REVEALED THE END OF SERVICE CONDITION WAS NOT CONFIRMED. MOREOVER, THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. MOREOVER, THE PATIENT'S CAUSE FOR THE INCREASE IN SEIZURES IS NOT KNOWN AS WELL AS THE RELATIONSHIP TO VNS AS THE DEVICE WAS NOT FOUND TO HAVE MET THE END OF SERVICE CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSE GEN MODEL 102		LYJ	CYBERONICS, INC.	101	1934

Patients

Seq	Age	Sex	Outcome	Treatment
1	15 YR		Required Intervention