BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2895484 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00023
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    May 18, 2011
    Report Date
    December 5, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    THE EXPLANTED GENERATOR WAS RETURNED ON (B)(4) 2013 AND IS PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WOULD BE SCHEDULED FOR SURGERY. ON (B)(6) 2013 THE PATIENT'S GENERATOR WAS REPLACED. THE LEAD WAS NOT REPLACED DURING THE SURGERY AS THE LEAD IMPEDANCE WAS FOUND TO BE OK. A RETURN PRODUCT KIT HAS BEEN SENT TO THE MEDICAL CENTER; HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT HE RECEIVED A HIGH IMPEDANCE ON THE PATIENT ON (B)(6) 2012. HE SAID THAT PREVIOUSLY HE WAS UNABLE TO GET THE PATIENT ABOVE 0.50MA AND THAT HE SET HER ON 1.25MA DURING THIS OFFICE VISIT; HOWEVER, THE PATIENT WAS UNABLE TO FEEL THE STIMULATION. IT IS UNKNOWN WHY THE PATIENT'S SETTINGS COULD NOT BE INCREASED ABOVE 0.5MA IN THE PAST. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A REVIEW OF PROGRAMMING HISTORY FOUND THAT HIGH IMPEDANCE WAS NOTED ON THE LAST TWO SYSTEM DIAGNOSTIC TESTS PERFORMED, DATED (B)(6) 2011 AND (B)(6) 2012. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN SET TO 1.0MA OR GREATER OUTPUT CURRENT FROM (B)(6) 2010 DESPITE THE REPORT THAT THE PATIENT'S SETTINGS COULD NOT BE INCREASED ABOVE 0.5MA IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2270

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female