BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6173353 · Received December 14, 2016

    Report

    Report Number
    3004209178-2016-26409
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    December 2, 2016
    Report Date
    January 25, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR NON-MALIGNANT PAIN REPORTED ABOUT A WEEK AGO THEY HAD ADAPTIVESTIM ACTIVATED, BUT IT SEEMED THE STIMULATOR SEEMED TO BE TURNING OFF AND ON BY ITSELF EVEN THOUGH THEY WEREN¿T MOVING. THE CONSUMER SPOKE WITH THE MANUFACTURER¿S REPRESENTATIVE (REP) WHO ASKED THEM TO SEE WHAT LETTER THEY WERE ON, BUT WHEN THE CONSUMER PUT THE ANTENNA OVER THE IMPLANT THEY NOTICED THE INTENSITY CHANGED. IT WAS NOTED THE CONSUMER WEIGHED (B)(6) SO YOU COULD SEE THE BATTERY IN THE RIGHT BUTT AREA BUT THEY WERE UNABLE TO CHARGE THE BATTERY WHEN SITTING BECAUSE OF THE POSITION OF THE BATTERY. DURING THE CALL THE PATIENT PROGRAMMER (PP) WAS USED TO CHECK THE DEVICE WHICH SHOWED THE INTENSITY NUMBER HAD ACTUALLY CHANGED AND WAS SHOWING THEY WERE IN THE UPRIGHT POSITION WHEN IT SHOULD BE SHOWING THEY WERE SITTING. IT WAS NOTED ONE NIGHT WHEN CHARGING THE CONSUMER FELT ¿BUZZING AND STUFF¿ IN THEIR LIMBS ALL THE TIME EVEN THOUGH THEY DIDN¿T EVEN REALIZE IT TURNED ON WHEN THEY WERE TRYING TO CHARGE BECAUSE WHEN IT DID COME ON THEY COULD REALLY TELL IT CAME ON EVEN THOUGH THEY NEVER TURNED IT OFF. FOLLOWING THIS THE CONSUMER WAS OFFERED THE OPTION OF TURNING ADAPTIVESTIM OFF UNTIL THEY SAW THEIR HEALTHCARE PROVIDER (HCP) BUT THEY STATED IT WASN¿T CAUSING THEM DISCOMFORT BUT WAS MAKING THEM MORE AWARE OF WHAT WAS GOING ON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT INDICATING THAT THEIR DEVICE WAS REPROGRAMMED BY A MANUFACTURER REPRESENTATIVE. THE PATIENT IS HOPING THAT THE REPROGRAMMING WILL RESPOND CORRECTLY TO RESOLVE THE STIMULATION TURNING ON/OFF AND THE UNRESPONSIVE ADAPTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823811 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR