BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2483259 · Received March 8, 2012

    Report

    Report Number
    3004209178-2012-01433
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Report Date
    February 13, 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 377675 LOT V000965 IMPLANTED:(B)(6) 2006 EXPLANTED:NA. LEAD MODEL 377675 LOT V000965 IMPLANTED:(B)(6) 2006 EXPLANTED:NA. PROGRAMMER MODEL 37742 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED INITIALLY THAT THE PATIENT'S DEVICE WAS IN ITS SECOND OVERDISCHARGE. (THE FIRST OVERDISCHARGE WAS DUE TO BEING IN CARDIAC REHABILITATION FOR 9 MONTHS; THE PATIENT WAS TOO SICK TO CHARGE). THE PATIENT HAD STOPPED USING THE DEVICE A YEAR PRIOR AS IT WOULD NOT HOLD A CHARGE FOR MORE THAN A HALF A DAY AND HAD NO PAIN RELIEF. THE PATIENT HAD ATTEMPTED TO GET THE DEVICE TO RESET. HIS CAREGIVER SPECULATED IF THE PATIENT WAS RECHARGING WHEN HE THOUGHT HE WAS. FURTHER INFORMATION INDICATED THAT THE PATIENT WAS FINALLY ABLE TO GET THE BATTERY CHARGED. THE DEVICE WENT INTO POWER ON RESET (POR). THE COMPANY REPRESENTATIVE INTERROGATED THE DEVICE WITH GOOD COUPLING, BUT THE DEVICE WENT INTO END OF SERVICE (EOS) AND WOULD NOT TURN ON. THE PATIENT PLANNED TO REQUEST A BATTERY CHANGE FROM HIS PHYSICIAN. ADDITIONAL FOLLOW UP WAS REQUESTED. 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 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1