FDA Adverse Event Malfunction Summary report: N

PROGRAMMING SOFTWARE

MDR report key: 1834523 · Received September 10, 2010

Report

Report Number: 1644487-2010-02073
Event Type: Malfunction
Date Received: September 10, 2010
Date of Event: July 1, 2010
Report Date: August 12, 2010
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED BY THE TREATING NEUROLOGIST ON (B)(6) 2010 THAT WHEN THE VNS PATIENT WAS SEEN FOR A FOLLOW-UP APPOINTMENT, AND UPON INTERROGATION OF THE PULSE GENERATOR, IT WAS NOTED THAT THE DEVICE WAS NOT AT THE INTENDED SETTINGS. THE PHYSICIAN REPORTED THAT THE PULSE WIDTH AND OUTPUT CURRENT WERE DIFFERENT THAN THE LAST TIME THE PATIENT WAS SEEN, WHICH WAS IN (B)(6), 2010. THE PATIENT WAS SEEN BY A DIFFERENT NEUROLOGIST AT THE OFFICE AT THAT FOLLOW-UP APPOINTMENT THAT OCCURRED IN (B)(6) 2010. PROGRAMMING AND DIAGNOSTIC HISTORY WAS RECEIVED FROM ONE OF THE REPORTING NEUROLOGIST'S HAND HELDS. REVIEW OF THE HISTORY REVEALED THAT ON (B)(6) 2010, UPON INTERROGATION, THE OFF TIME WAS NOTED TO BE 60 MINUTES. THERE WAS NO DATA FROM (B)(6) 2010 RECEIVED ON THE FLASHCARD RETURNED TO MANUFACTURER. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL PROGRAMMING HISTORY ARE CURRENTLY UNDERWAY. THE PATIENT HAD EXPERIENCED AN INCREASE IN SEIZURE ACTIVITY DUE TO THE CHANGE IN DEVICE SETTINGS. THE PHYSICIAN SUBSEQUENTLY REFERRED THE PATIENT TO THE SURGEON FOR A CONSULTATION. THE SURGEON OPTED TO REPLACE THE PULSE GENERATOR, PRESUMABLY DUE TO THE INCREASE IN SEIZURE FREQUENCY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROGRAMMING SOFTWARE		LYJ	CYBERONICS, INC.	MODEL 250

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Required Intervention