BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1833656 · Received September 10, 2010

    Report

    Report Number
    1644487-2010-02077
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 12, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD SURGERY TO REMOVE THE VNS DEVICE DUE TO INFECTION AND CELLULITIS. PT WENT TO ER ON (B)(6)2010 AS HER CAREGIVERS FOUND THE GENERATOR SITE HAD OPENED UP (GENERATOR WAS VISIBLE) AND WAS DRAINING. PHYSICIAN PRESCRIBED ANTIBIOTICS. THE DEVICE WAS REMOVED (B)(6)2010 AND THE INFECTION SITE WAS DEBRIDED AND CLEANED. THE SURGEON THOUGHT PERHAPS THE PT'S BODY HAD REJECTED THE IMPLANT WHICH CAUSED THE INFECTION. HOWEVER, PER NEUROLOGIST, THE GENERATOR BECAME LOOSE AND MIGRATED SLOWLY OVER 5 YEARS TO THE PT'S ARMPIT, AND CAME OUT. ONCE IT WAS EXPOSED TO AIR, THE INFECTION STARTED. IT WAS ALSO NOTED THAT THE PT WAS LIKELY MANIPULATING THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE EVENTS. PT WILL BE REIMPLANTED IN THE FUTURE IN A DIFFERENT LOCATION TO PREVENT PT MANIPULATION OF THE DEVICE. EXPLANTED PRODUCT WAS RETURNED TO THE MFR AND UNDERWENT ANALYSIS. UPON ANALYSIS, NO ANOMALIES WERE NOTED. REVIEW OF MFG RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 010093

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R