PULSE GEN MODEL 103

Report

Report Number: 1644487-2014-01856
Event Type: Injury
Date Received: July 23, 2014
Date of Event: January 1, 2014
Report Date: June 26, 2014
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Description of Event or Problem · 1

THE EXPLANTED GENERATOR WAS RECEIVED FOR ANALYSIS. THE RETURNED PRODUCT FORM INDICATED THAT THE GENERATOR WAS REPLACED DUE TO END OF SERVICE. ANALYSIS OF THE GENERATOR WAS COMPLETED ON 09/22/2014. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

Description of Event or Problem · 1

CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT USUALLY AVERAGED FOUR TO FIVE SEIZURES A MONTH AND THAT IN THE LAST TWO MONTHS SINCE THE LAST VISIT, THE SEIZURES HAVE BEEN STABLE WITH FIVE OR SIX A MONTH. IT WAS NOTED THAT THE PATIENT HAS HAD A FEW MORE CLUSTERS THAN USUAL, WITH TWO OR THREE SEIZURES HAPPENING A FEW HOURS APART. IT WAS NOTED THAT THE BATTERY LIFE IS AT TWENTY PERCENT AND IFI = YES. THE PATIENT'S MOTHER REPORTS A SLIGHT CHANGE IN SEIZURES IN THE FORM OF CLUSTERING. IT WAS NOTED THAT THE PATIENT WOULD BE REFERRED FOR GENERATOR REPLACEMENT AS THIS MAY BE THE REASON FOR A MILD WORSENING OF SEIZURES. THE PATIENT UNDERWENT GENERATOR REPLACEMENT. THE GENERATOR HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
431524	PULSE GEN MODEL 103	GENERATOR	LYJ	CYBERONICS, INC.	103	201195

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR		Required Intervention