BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS PATIENT PROGRAMMER

    MDR report key: 2940980 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-00066
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT ((B)(6)) WAS UNABLE TO DECREASE THE AMPLITUDE OF HER STIMULATION AS THE MINUS BUTTON ON THE PROGRAMMER WAS NO LONGER FUNCTIONING. A REPLACEMENT PROGRAMMER WAS PROVIDED TO THE PATIENT THEREBY RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40272 GENESIS PATIENT PROGRAMMER SCS PROGRAMMER LGW ST. JUDE MEDICAL - NEUROMODULATION 3850 3262419

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention