PULSE GEN MODEL 102

MDR report key: 2831209 · Received November 14, 2012

Report

Report Number: 1644487-2012-02991
Event Type: Injury
Date Received: November 14, 2012
Date of Event: February 27, 2011
Report Date: October 15, 2012
Manufacturer: CYBERONICS INC
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REVIEW OF PROGRAMMING HISTORY.

Description of Event or Problem · 1

CLINIC NOTES DATED (B)(6) 2012 WERE RECEIVED ON (B)(6) 2012. THE PATIENT WAS SEIZURE FREE FROM (B)(6) 2009 TO (B)(6) 2010. THE NOTES INDICATED THAT THIS VNS PATIENT EXPERIENCED A SEIZURE ON (B)(6)2011. THE PATIENT AWOKE WITH AN UPSET STOMACH, SAT UP IN BED, WAS STARTING AND NON-RESPONSIVE, HER BODY WENT LIMP, AND SHE LOST COLOR IN HER FACE AND HANDS FOR A FEW SECONDS. THE PATIENT'S MEDIATION WAS INCREASED. IN (B)(6) 2011, THE PATIENT HAD TWO EPISODES OF STARING, EACH LASTING 2 MINUTES FOLLOWED BY POST-ICTAL SLEEPINESS. ONE EPISODE OCCURRED AFTER THE PATIENT'S MEDICATION DOSE WAS INCREASED. THE PATIENT HAD A BIGGER SEIZURE ON (B)(6) 2011. THE SEIZURES STARTED WITH HER STOMACH HURTING AND FEELING NAUSEOUS. SHE THEN BECAME NON-RESPONSIVE, FELL OVER, AND STARTED HAVING CONVULSIONS. THE VNS MAGNET WAS SWIPED TWICE AT THE END OF THE SEIZURE, WHICH LASTED 3 MINUTES IN DURATION. OXYGEN WAS ADMINISTERED, AND THE PATIENT'S VITALS WERE STABLE. SHE WAS NOT TRANSPORTED. THE PATIENT'S MEDICATION WAS INCREASED. A NORMAL MODE DIAGNOSTIC ON (B)(6) 2011 AND ON (B)(6) 2011 WERE WITHIN NORMAL LIMITS. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSE GEN MODEL 102	GENERATOR	LYJ	CYBERONICS INC	102	016932

Patients

Seq	Age	Sex	Outcome	Treatment
1	8 YR		Required Intervention