PULSE GEN MODEL 103

Report

Report Number: 1644487-2012-03254
Event Type: Malfunction
Date Received: December 10, 2012
Date of Event: November 6, 2012
Report Date: November 9, 2012
Manufacturer: CYBERONICS, INC.
Product Code: LYJ
PMA / PMN Number: P970003
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF GENERATOR.

Additional Manufacturer Narrative · 1

DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY ANOMALIES.

Description of Event or Problem · 1

IT WAS REPORTED ON (B)(6) 2012 THAT THE PATIENT WAS SEEN FOR FOLLOW UP AND HIGH IMPEDANCE WAS OBSERVED, 10,000 OHMS. THE PATIENT WAS NOT IN PAIN, BUT IT WAS NOTED THAT SHE HAD A RECENT FALL DUE TO A SEIZURE. X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW. THE GENERATOR AND THE LEAD CAN BE VISUALIZED. THE CONNECTOR PIN DOES NOT APPEAR TO BE FULLY INSERTED AS IT CANNOT BE VISUALIZED PAST THE SECOND CONNECTOR BLOCK. THE GENERATOR SEEMS TO BE PLACED IN A NORMAL POSITION AND THE FEEDTHRU WIRE APPEARS TO BE INTACT. THE LEAD WAS VISUALIZED ROUTED FROM THE GENERATOR TOWARDS THE LEFT NECK. A PORTION OF THE LEAD APPEARS TO BE BEHIND THE GENERATOR AND THEREFORE CANNOT BE ASSESSED. THERE APPEARS TO BE NO FRACTURES, DISCONTINUITIES OR ANY SHARP ANGLES PRESENT IN THE LEAD, AND THE LEAD WIRE APPEAR INTACT AT THE CONNECTOR PIN. BASED ON THE X-RAY IMAGES PROVIDED, AN EXACT CAUSE FOR THE REPORT OF HIGH IMPEDANCE COULD NOT BE CONFIRMED HOWEVER THE LEAD PIN DID NOT APPEAR FULLY INSERTED INTO THE GENERATOR. ADDITIONAL INFORMATION WAS THEN RECEIVED INDICATING THAT PRIOR TO THE OBSERVED HIGH IMPEDANCE; THE PHYSICIANS HAD NOTICED AN INCREASE IN HER SEIZURE FREQUENCY, BUT THERE WAS NO NOTED TRAUMA OR MANIPULATION. ADDITIONALLY THE PATIENT HAD STARTED TO EXPERIENCE PAIN IN HER LEFT CHEST NEAR THE GENERATOR A FEW WEEKS PRIOR. PER THE PHYSICIAN, THE HIGH IMPEDANCE WAS FIRST NOTED ON (B)(6) 2012 AND THE DEVICE WAS DISABLED AT THAT TIME. SURGERY OCCURRED ON (B)(6) 2012. THE GENERATOR WAS REPLACED, HOWEVER, IT WAS INDICATED THAT THE ISSUE APPEARED TO BE WITH PIN INSERTION AS FOLLOWING RE-INSERTION, THE DIAGNOSTICS WERE WITHIN NORMAL LIMITS.

Description of Event or Problem · 1

ATTEMPTS FOR THE RETURN OF THE GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE. A REVIEW OF THE DESIGN MANUFACTURING RECORDS OF THE PATIENT'S IMPLANTED GENERATOR WAS PERFORMED ON (B)(6) 2013 AND NO NON-CONFORMANCES WERE OBSERVED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 WHEN THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PRODUCT ANALYSIS LAB AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. BURN MARKS WERE ALSO OBSERVED ON THE PULSE GENERATOR HEADER, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING THE EXPLANT PROCEDURE. ONCE THE OUTPUT WAS RE-ENABLED, RESULTS OF ELECTRICAL TEST RESULTS DEMONSTRATED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. RESULTS OF DIAGNOSTIC TESTING AND MONITORING INDICATED THE DEVICE WAS OPERATING PROPERLY. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSE GEN MODEL 103	GENERATOR	LYJ	CYBERONICS, INC.	103	3125

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR		Required Intervention