BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3920074 · Received July 8, 2014

    Report

    Report Number
    1644487-2014-01730
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE. X-RAYS WERE TAKEN AND WERE REPORTED BY THE PHYSICIAN TO BE UNREMARKABLE. NO PATIENT TRAUMA WAS REPORTED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PATIENT RECENTLY UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. THE PATIENT¿S REPLACEMENT GENERATOR HAD NOT BEEN TESTED WITH THE PATIENT¿S EXISTING LEAD PRIOR TO THE OFFICE VISIT ON (B)(6) 2014. THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON 06/21/2014. THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, NO ANALYSIS CAN BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396746 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 18524C

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR