BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2993250 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00633
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 15, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    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.

    Description of Event or Problem · 1

    REPORTER INDICATED INTERMITTENT HIGH LEAD IMPEDANCE WAS NOTED FOR A PATIENT WHO RECENTLY HAD VNS GENERATOR REPLACEMENT ON (B)(6) 2013. THE PATIENT HAD NO KNOWN TRAUMA. THE PATIENT IS ALSO EXPERIENCING PAINFUL STIMULATION AT THE ELECTRODE SITE IN THE NECK. X-RAYS WERE REVIEWED BY THE MANUFACTURER. THE ELECTRODES ARE VISUALIZED AT APPROXIMATELY T1 AND ARE IN ALIGNMENT; THE ELECTRODES ARE IMPLANTED LOWER THAN WHAT IS USUALLY SEEN. THE GENERATOR IS IMPLANTED IN THE LEFT AXILLA. THIS IS MUCH MORE LATERAL THAN WHAT IS NORMALLY SEEN. THE VIEW DOES NOT ALLOW FULL ASSESSMENT OF THE LEAD PIN INSERTION. THE LEAD WIRE IS INTACT AT THE LEAD PIN. THE FILTER FEEDTHROUGHS ARE INTACT. THERE IS A SMALL AMOUNT OF LEAD BEHIND THE GENERATOR THAT CANNOT BE ASSESSED. THE CAUSE OF THE HIGH LEAD IMPEDANCE IS UNKNOWN AT THIS TIME, BUT MAY BE DUE TO INADEQUATE PIN INSERTION OR A LEAD FRACTURE. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    ADDITIONAL X-RAYS WERE REVIEWED BY THE MANUFACTURER. THE LEAD PIN DID NOT APPEAR TO BE FULLY INSERTED. NO ADDITIONAL ANOMALIES WERE NOTED. THE SURGEON INDICATED HE FELT THE LEAD PIN HAD BEEN FULLY INSERTED AS TWO AUDIBLE CLICKS WERE HEARD WHEN TIGHTENING THE SETSCREW. HOWEVER, THE POSSIBILITY OF A LEAD FRACTURE MAY ALSO EXIST. REPORTER INDICATED THE PATIENT WAS ALSO HAVING INCREASED SEIZURES AND THAT THE PLAN OF CARE IS TO HAVE VNS REVISION SURGERY; HOWEVER, THIS HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    MANUFACTURER REVIEW OF THE DEVICE HISTORY RECORDS FOR THE VNS LEAD AND GENERATOR CONFIRMED BOTH DEVICES PASSED ALL FINAL TESTING PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT HAD VNS LEAD PIN REINSERTION SURGERY PERFORMED ON (B)(6) 2013. AFTER THE LEAD PIN WAS REINSERTED INTO THE GENERATOR HEADER, DIAGNOSTICS WERE WITHIN NORMAL LIMITS (3218 OHMS). NO NEW DEVICES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96995 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 303-20 2526

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR