PULSE GEN MODEL 103

Report

Report Number: 1644487-2012-03169
Event Type: Injury
Date Received: December 3, 2012
Date of Event: September 18, 2012
Report Date: November 8, 2012
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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Description of Event or Problem · 1

ON (B)(6) 2012, CLINIC NOTES WERE RECEIVED FROM A VNS TREATING PHYSICIAN DATED (B)(6) 2012, WHICH INDICATED THAT THE PATIENT'S SEIZURE ACTIVITY HAS WORSENED SLIGHTLY. THE MAJORITY OF THE PATIENT'S SEIZURES ARE DROP SEIZURES. IT WAS REPORTED THAT THE VNS WAS INTERROGATED AND THE BATTERY WAS LOW. THE PATIENT WAS REFERRED FOR BATTERY REPLACEMENT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE NURSE PRACTITIONER HAVE BEEN MADE BUT HAVE BEEN UNSUCCESSFUL.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHEN IT WAS REPORTED THAT THE LEAD IMPEDANCE AFTER SURGERY WAS "OK" AND WAS A VALUE OF 2272OHMS.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN IT WAS REPORTED THAT THE PATIENT HAD HIS GENERATOR REPLACED DUE TO END OF SERVICE THAT DAY. PRE-OPERATIVE DIAGNOSTICS WERE PERFORMED WHICH SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=2356OHMS/NEOS=YES. THE PHYSICIAN REPORTED THAT THERE WAS NOT AN INCREASE IN SEIZURES FROM (B)(6) 2012; THE PATIENT'S SEIZURES WERE STABLE. THE PHYSICIAN FURTHER SAID THAT THE SEIZURES WERE NOT RELATED TO VNS BUT THERE WAS NO INCREASE IN SEIZURES REPORTED. THE EXPLANTED GENERATOR COULD NOT BE RETURNED FOR PRODUCT ANALYSIS AS THE HOSPITAL DOES NOT RETURN EXPLANTED DEVICES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSE GEN MODEL 103	GENERATOR	LYJ	CYBERONICS, INC.	103	1952

Patients

Seq	Age	Sex	Outcome	Treatment
1	16 YR		Other