BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2900166 · Received January 7, 2013

    Report

    Report Number
    1644487-2013-00076
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    ON (B)(4) 2012 IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED AT THE PATIENT'S LAST VISIT. X-RAYS WERE RECEIVED AND THE LEAD CONNECTOR PIN APPEARS TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE LEAD WIRES AT THE CONNECTOR PIN APPEAR TO BE INTACT. PART OF THE LEAD BODY WAS BEHIND THE GENERATOR AND COULD NOT BE ASSESSED. NO ACUTE ANGLES OR FRACTURES COULD BE FOUND IN THE PORTIONS OF THE LEAD THAT COULD BE FULLY ASSESSED. BASED ON THE X-RAYS RECEIVED, A CAUSE FOR THE REPORTED HIGH IMPEDANCE COULD NOT BE DETERMINED. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8049 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR