BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2063270 · Received March 22, 2011

    Report

    Report Number
    1644487-2011-00606
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFG RECORDS WERE REVIEWED. REVIEW OF THE MFG RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS TO HAVE ROUTINE GENERATOR REPLACEMENT SURGERY ON (B)(6) 2011. UPON OPENING THE GENERATOR POCKET IN THE SURGERY, IT WAS NOTED THE LEAD PINS WERE BENT, AND THE POCKET AREA APPEARED TO BE GREEN AND BLACK IN COLOR. IT WAS STATED THERE WAS A POSSIBILITY OF INFECTION, AND ONLY THE GENERATOR WAS EXPLANTED AT THAT TIME. THE PT'S VNS LEAD WAS LATER EXPLANTED AND A NEW VNS SYSTEM WAS IMPLANTED ON (B)(6) 2011. AN IMPLANT CARD RECEIVED TO THE MFR STATED IT APPEARED THE PT HAD A REACTION TO A LEAD FRACTURE. THE EXPLANTED DEVICES HAVE BEEN RETURNED FOR ANALYSIS WITH PAPERWORK INDICATING THE PT HAD MANIPULATED THE VNS BY PULLING AT THE GENERATOR DURING A SEIZURE. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 011066

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention