BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 3983628 · Received August 6, 2014

    Report

    Report Number
    3007566237-2014-02197
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE COMPANY REPRESENTATIVE SPOKE TO THE CLINIC AND DETERMINED THAT NO ONE HAD SEEN THE PATIENT. THE PATIENT HAD SINCE BEEN REFERRED TO A DIFFERENT PAIN CLINIC. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WOULD BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S SPINAL CORD STIMULATION (SCS) ¿DEVICE WASN¿T WORKING¿ AND NOTED THAT THE PATIENT TOLD THE HEALTHCARE PROFESSIONAL (HCP) THIS IN (B)(6). IT WAS NOTED THAT THE HCP WANTED TO BE PUT IN TOUCH WITH A MANUFACTURER¿S REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT¿S INFORMATION WAS PROVIDED BUT THE PATIENT WAS NOT FOUND IN THE DATABASE. DEVICE INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S ISSUE HAD BEEN RESOLVED BY REPROGRAMMING PERFORMED BY A MANUFACTURER¿S REPRESENTATIVE, AND THAT ¿THERE WAS NO NEED TO FOLLOW UP WITH ANYBODY.¿ IT WAS NOTED THAT THE HCP DID NOT HAVE THE SERIAL NUMBERS ON FILE AND THE CALLER SOUNDED AGITATED BY THE QUESTIONING. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE WOULD BE CONTACTED FOR FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461116 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR