BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPUSTIM TRANSMITTER

    MDR report key: 1963417 · Received December 20, 2010

    Report

    Report Number
    1627487-2010-03959
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    SJM NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 1999. IT WAS REPORTED THAT THE PATIENT COULD TURN STIMULATION ALL THE WAY UP BUT DOES NOT FEEL STIMULATION. THE PATIENT WILL DISCUSS HIS OPTIONS WITH HIS PHYSICIAN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPUSTIM TRANSMITTER SPINAL CORD STIMULATION TRANSMITTER LGW SJM NEUROMODULATION DIVISION MNT98CC A7786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention