BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2102256 · Received May 19, 2011

    Report

    Report Number
    1644487-2011-01125
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 BY A NURSE THAT A PT HAD HIGH IMPEDANCE. THE PT WAS SENT FOR X-RAYS AS WELL AS A REVISION SURGERY. FURTHERMORE, THERE WAS NO REPORT OF TRAUMA OR MANIPULATION, AND THE X-RAYS WERE NOT GOING TO BE SENT TO THE MANUFACTURER FOR REVIEW. THE PT SUBSEQUENTLY UNDERWENT A FULL REVISION SURGERY. LAST KNOWN DIAGNOSTICS ON (B)(6) 2010 IN THE MANUFACTURER'S DATABASE WERE WITHIN NORMAL LIMITS. ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5316

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR