PULSE GEN MODEL 102

MDR report key: 3253134 · Received July 29, 2013

Report

Report Number: 1644487-2013-02242
Event Type: Death
Date Received: July 29, 2013
Date of Event: June 30, 2013
Report Date: July 1, 2013
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF PROGRAMMING HISTORY.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE DEATH WAS DUE TO SEPSIS AND RESPIRATORY FAILURE. THE DEATH WAS NOT RELATED TO SUDEP OR VNS. THE PATIENT HAD 2 SEIZURES ON (B)(6) 2013 AND WAS GIVEN DIASTAT. THE PATIENT THEN HAD 3 MORE SEIZURES AND WAS SENT TO THE EMERGENCY ROOM AND WAS ADMITTED. THE PATIENT WAS DIAGNOSED WITH RECURRENT SEIZURES, A URINARY TRACT INFECTION, HYPONATREMIA, HYPOTHYROIDISM, HYPOTENSION AND DEVELOPED RENAL FAILURE.

Description of Event or Problem · 1

ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT DIED ON (B)(6) 2013 DUE TO MULTIPLE SEIZURES. THE PATIENT WAS SCHEDULED FOR A BATTERY REPLACEMENT IN (B)(6) 2013 DUE TO THEIR DEVICE BEING AT END OF SERVICE. THIS DEATH EVENT HAS BEEN REVIEWED AND WITH THE AVAILABLE INFORMATION HAS BEEN DETERMINED NOT TO BE SUDEP. WITH THE AVAILABLE INFORMATION, THE DEATH WAS DUE TO MULTIPLE SEIZURES. GOOD FAITH ATTEMPTS ARE CURRENTLY BEING PERFORMED FOR ADDITIONAL INFORMATION.

Description of Event or Problem · 1

FOLLOW-UP WITH THE FUNERAL HOME SHOWED THAT THE PATIENT WAS BURIED WITH THE DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
353043	PULSE GEN MODEL 102	GENERATOR	LYJ	CYBERONICS, INC.	102	201201

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Death