BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2880107 · Received December 19, 2012

    Report

    Report Number
    1644487-2012-03399
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    May 2, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THROUGH AN IMPLANT AND WARRANTY REGISTRATION CARD THAT A VNS PATIENT HAD UNDERGONE A FULL SYSTEM REPLACEMENT DUE TO LEAD DISCONTINUITY. THE DEVICE WAS DISABLED ON (B)(6) 2012. FURTHER INFORMATION WAS RECEIVED FROM THEIR FOLLOW UP PHYSICIAN STATING THAT X-RAYS WERE TAKEN BUT HAD YIELDED NO SIGNIFICANT FINDINGS. THE PATIENT USED TO PLAY WITH THE LEAD AND THIS WAS BELIEVED TO HAVE CAUSED THE LEAD FRACTURE. ALTHOUGH WHEN THE EVENT OCCURRED IS NOT KNOWN AT THIS TIME. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE GENERATOR WAS EXPLANTED PROPHYLACTICALLY IN ORDER TO AVOID A SECOND OPERATION IN THE FUTURE FOR THE BATTERY REPLACEMENT AND IN ORDER TO AVOID THE RISK OF SURGICAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS INC 302-UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR