BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3173723 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10484
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER; PRODUCT ID 377860, LOT# V014257, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377860, LOT# V013676, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S RECHARGER WAS NOT CHARGING AND THE RECHARGER KEPT TURNING OFF WHEN TRYING TO CHARGE THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THE MIDDLE ICON ON THE TOP ROW OF THE PROGRAMMER WAS ONLY HALF AND KEPT STAYING AT HALF AND THE PROGRAMMER ICON WAS FULL. IT WAS NOTED THE PATIENT DIDN¿T KNOW WHY IT DIDN¿T CHANGE. REPORTEDLY, THE PATIENT WAS ABLE TO DECREASE THEIR STIMULATION BUT COULD NOT INCREASE THE STIMULATION DUE TO THE INS BEING OFF. THE PATIENT STATED THEIR INS DIDN¿T WORK.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT'S BATTERY WOULD NOT CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273829 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 00078 YR