PULSE GEN MODEL 102

Report

Report Number: 1644487-2014-01425
Event Type: Malfunction
Date Received: June 6, 2014
Date of Event: May 7, 2014
Report Date: May 8, 2014
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN LOW IMPEDANCE (DC DC CODE - 0). IT WAS REPORTED THAT DEVICE DIAGNOSTICS HAVE DECREASED OVER A PERIOD OF TIME. THE PATIENT'S PARENTS REPORTED AN INCREASE IN SEIZURES; HOWEVER, IT WAS REPORTED THAT THIS IS HARD TO QUANTIFY AS THE BASELINE WAS HIGH TO START OFF WITH. THE PARENTS ALSO MENTIONED THAT THE PATIENT WAS "BASHED" IN THE CHEST 3 WEEKS PRIOR. THE PATIENT WAS SCHEDULED FOR SURGERY AND THE PLAN WAS TO REPLACE THE GENERATOR FIRST TO SEE IF THE IMPEDANCE INCREASED AND IF NOT A LEAD REPLACEMENT WOULD ALSO BE PERFORMED. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. PRE-OPERATIVE DIAGNOSTICS CONFIRMED LOW IMPEDANCE (DC DC CODE - 0). THE GENERATOR WAS REPLACED AND DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS (IMPEDANCE VALUE - 2,029 OHMS). THE LEAD WAS NOT REPLACED.

Description of Event or Problem · 1

THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. MONITORING OF THE GENERATOR OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS, THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
330680	PULSE GEN MODEL 102	GENERATOR	LYJ	CYBERONICS, INC.	102	016066

Patients

Seq	Age	Sex	Outcome	Treatment
1