BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2566866 · Received May 9, 2012

    Report

    Report Number
    3004209178-2012-03145
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 12, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399930, LOT # V043269, IMPLANTED: (B)(6 2007, PRODUCT TYPE LEAD. PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER. PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEEDED REPROGRAMMING, SPECIFICALLY, A NEW ELECTRODE COMBINATION. IT WAS NOTED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT'S STIMULATION WAS "VERY LIGHT." NO ABNORMAL IMPEDANCE VALUES WERE DETECTED. REPROGRAMMING AND THE "APPLICATION OF MORE POWER" IN (B)(6) 2012 WERE SUCCESSFUL AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ISSUE WITH THE PATIENT PROGRAMMER. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE PATIENT HAD TRIED FRESH BATTERIES FROM THE STORE AT LEAST 3 TIMES. THERE WERE VERTICAL LINES ON THE PATIENT PROGRAMMER SCREEN AND THE PATIENT PROGRAMMER DID NOT RESPOND. IT WAS NOTED THE PATIENT MAY HAVE DROPPED THE PATIENT PROGRAMMER BUT HE WAS NOT SURE. THE PATIENT WAS EXPERIENCING ACUTE PAIN. THE PATIENT HAD BEEN IN MORE PAIN BEGINNING TODAY ((B)(6) 2012). THE PATIENT HAD NO STIMULATION SENSATION AND COULDN'T GET HIS PATIENT PROGRAMMER TO FUNCTION PROPERLY. THE PATIENT WAS ASSISTED WITH TURNING ON HIS INS VIA THE INSR. THE PATIENT COULD THEN FEEL STIMULATION BUT STATED IT WAS NOT A VERY STRONG STIMULATION SENSATION. THE PATIENT'S PROGRAMMER WAS STILL NOT FUNCTIONING FOLLOWING ASSISTANCE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR