BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2474611 · Received March 1, 2012

    Report

    Report Number
    3004209178-2012-01298
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Report Date
    February 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 377875, LOT #V001117, IMPLANTED: (B)(6) 2006, LEAD: MODEL 377875, LOT #V001117, IMPLANTED: (B)(6) 2006, PROGRAMMER: MODEL 37742, SERIAL: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS CHARGING MORE THAN EXPECTED. THE PATIENT WAS RECHARGING THE DEVICE APPROXIMATELY EVERY 2 DAYS FOR 1.5 TO 3 HOURS WITH EACH SESSION, AND THE PATIENT WAS INITIATING RECHARGING WHEN THE BATTERY STILL HAD 25-50% OF ITS POWER REMAINING. THE RECHARGE INTERVAL WAS CALCULATED AND THE RESULTS INDICATED THE PATIENT'S RECHARGE FREQUENCY AND BATTERY DEPLETION WERE APPROPRIATE BASED ON THE PATIENT'S SETTINGS AND AGE OF THE BATTERY (6 YEARS OLD OUT OF A POSSIBLE 9 YEARS). THE PATIENT'S RECHARGE STATISTICS ALSO INDICATED THE PATIENT WAS CONSISTENTLY GETTING ALL 8 COUPLING BARS WHILE RECHARGING. IMPEDANCES WERE MEASURED AND THE RESULTS INDICATED THERE WAS AN OPEN CIRCUIT ON ELECTRODE 7 AND THERE WERE SOME ELEVATED IMPEDANCES ON ELECTRODE 12. THE HIGH IMPEDANCES WOULD NOT NEGATIVELY AFFECT THE BATTERY DRAIN THOUGH. THERE WAS NO EVIDENCE OF ANY SHORT CIRCUITS, AND THE REST OF THE IMPEDANCES WERE "GOOD." NO FURTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1