BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3022977 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00828
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    December 18, 2012
    Report Date
    March 4, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED AND ANALYSIS OF PROGRAMMING HISTORY OCCURRED. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT ON (B)(6)2012 A SYSTEM DIAGNOSTICS TEST WAS PERFORMED ON THE PATIENT WHICH SHOWED LOW OUTPUT; OUTPUT CURRENT= LOW/ CURRENT DELIVERED = 3.0MA/ LEAD IMPEDANCE = OK/ IMPEDANCE VALUE = 2381 OHMS/ IFI = NO. THE PATIENT'S SETTINGS ON (B)(6) 2102 WERE NOTED TO BE OUTPUT=3.25MA/FREQUENCY=30HZ/PULSE WIDTH=750USEC/ON TIME=30SEC/OFF TIME=3MIN/MAGNET OUTPUT=3.5MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC. THE MANUFACTURING RECORDS FOR THE GENERATOR WERE REVIEWED AND DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE PHYSICIAN LATER REPORTED THAT THE PATIENT HAS NOT BEEN SEEN SINCE (B)(6) 2012. HE ALSO REPORTED THAT HE DID NOT TRY TO LOWER THE PATIENT'S SETTINGS TO SEE IF THAT RESOLVED THE "LOW" OUTPUT DURING SYSTEM DIAGNOSTICS. THE PHYSICIAN STATED THAT NO INTERVENTIONS ARE PLANNED AS THE "VNS SEEMS TO BE WORKING OK." THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED IN THE DATABASE AND IT WAS OBSERVED THAT ON (B)(6) 2012 THE OUTPUT CURRENT ALSO SHOWED AS ¿LOW¿ DURING A SYSTEM DIAGNOSTICS TEST BUT WHEN THE PATIENT'S SETTINGS WERE LOWERED, THIS RESOLVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127213 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 3402

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR