BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 3971479 · Received July 31, 2014

    Report

    Report Number
    1644487-2014-01908
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CYBERONICS
    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.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    X-RAYS DATED (B)(6) 2014 WERE PROVIDED TO THE MANUFACTURER FOR FURTHER REVIEW. THE GENERATOR APPEARS IN THE LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES AND LEAD PIN INSERTION COULD NOT BE ASSESSED WITH THE IMAGES PROVIDED. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. NO CLEAR LEAD BREAKS OR SHARP ANGLES WERE FOUND IN THE PARTS OF THE LEAD THAT COULD BE ASSESSED. BASED ON THE IMAGES PROVIDED, THE CAUSE OF THE HIGH LEAD IMPEDANCE REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE (DC DC ¿ 7). THE PATIENT¿S DEVICE WAS SUBSEQUENTLY PROGRAMMED OFF. X-RAYS WERE TAKEN AND WERE REPORTED BY THE PHYSICIAN TO BE UNREMARKABLE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447133 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR