BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3404394 · Received October 10, 2013

    Report

    Report Number
    3004209178-2013-18847
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Report Date
    September 20, 2013
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-45, LOT# V216861, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-45, LOT# V191307, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MANUFACTURER REPRESENTATIVE SPOKE TO THE PATIENT THE DAY PRIOR TO THE REPORT, WHO COMPLAINED OF NOT BEING ABLE TO CHARGE THE IMPLANT. THE PATIENT STATED HE HAD QUIT USING STIMULATION CONSISTENTLY BECAUSE HE ¿JUST DID NOT FEEL LIKE IT WAS HELPING MUCH ANYMORE.¿ THE PATIENT WAS WALKED THROUGH USING THE ANTENNA LOCATE FEATURE WHICH LED TO A POWER ON RESET (POR) MESSAGE AFTER ONLY A ¿FEW MINUTES.¿ THE PATIENT WAS THEN ABLE TO RECHARGE THE BATTERY FULLY. THE POR WAS SEEN ON THE PATIENT PROGRAMMER AND THE PATIENT¿S FIRST OVERDISCHARGE WAS CONFIRMED. THE PATIENT HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. THE REPRESENTATIVE HOPED TO MEET THE PATIENT ON (B)(6) 2013 TO RESET THE DEVICE AND REPROGRAM IT FOR BETTER PAIN RELIEF. FOUR DAYS LATER THE SESSION DATA SHOWED IMPEDANCES THAT WERE GREATER THAN 3,600 OHMS ON ELECTRODE 10 AND ANY ASSOCIATED COMBINATIONS. LATER THAT DAY IT WAS REPORTED THAT THE PATIENT WAS SEEN ON THE DAY OF THE REPORT. THE DEVICE WAS ADEQUATELY CHARGED AND REPROGRAMMED FOR GREAT PAIN RELIEF IN BOTH THE PATIENT¿S LOWER EXTREMITIES AND LOWER BACK. A PHYSICIAN MODE RECHARGE (PMR) WAS NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521300 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1