BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6132737 · Received November 29, 2016

    Report

    Report Number
    3004209178-2016-24828
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 26, 2016
    Report Date
    November 29, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109490
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT¿S STIMULATION SENSATION ON GROUP E HAD CHANGED TO AN INTERMITTENT PULSE. BEFORE THIS IT WAS A CONSTANT PULSE. THERE WERE NO TRAUMA/FALLS REPORTED THAT COULD HAVE BEEN RELATED TO THIS ISSUE. THE PATIENT CHECKED THE DEVICE WITH THE PATIENT PROGRAMMER AND THEY HAD THE ABILITY TO CHANGE STIMULATION BUT THIS DID NOT RESOLVE THE ISSUE. THE PATIENT DID NOT HAVE ADAPTIVE STIMULATION. THE PATIENT HAD ANOTHER GROUP TO TRY AND THIS RESOLVED THE ISSUE. THE PATIENT WAS TO FOLLOW-UP WITH A HEALTHCARE PROFESSIONAL. THE CHANGE IN THERAPY/SYMPTOMS WAS NOTED TO HAVE BEEN GRADUAL. IT WAS NOTED THAT THE PATIENT HAD INTERMITTENT PAIN SO HE DID NOT NEED THERAPY ALL OF THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783354 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97713 00643169109490

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR