BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2981365 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00534
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 31, 2013
    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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAD HIGH IMPEDANCE AND STARTED TO HAVE INCREASE IN SEIZURES. THE PHYSICIAN ATTRIBUTES THE INCREASE IN SEIZURES TO THE LOSS OF THE VNS THERAPY. THE PATIENT HAD THE VNS LEAD AND GENERATOR REPLACED ON (B)(6) 2013. NO X-RAYS WERE TAKEN AND THE VNS GENERATOR AND LEAD WERE THROWN AWAY. THE LAST KNOW DIAGNOSTICS FOR THE VNS GENERATOR WAS IN (B)(6) 2011 WHICH SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/1617 OHMS/BATTERY= OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85666 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 2372

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention