BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1800045 · Received August 12, 2010

    Report

    Report Number
    3004209178-2010-06085
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PATIENT WAS KICKED ON THE IMPLANTABLE NEUROSTIMULATOR. AFTERWARD THE DEVICE BATTERY DEPLETED FROM A FULL CHARGE TO 75% CHARGED IN 2 DAYS. THE PATIENT CHARGED MORE THAN EXPECTED. THE DEVICE WAS PROGRAMMED TO DELIVER THERAPY USING 2 PROGRAMS, 8 ANODES AND 8 CATHODES ON EACH, PULSEWIDTH 450 MICROSECONDS, FREQUENCY 60 HERTZ, AMPLITUDE 0.6 VOLTS. IMPEDANCES WERE 350 OHMS FOR EACH PROGRAM. THE RECHARGE INTERVAL ON THE LONGEVITY CALCULATOR WAS ABOUT 22 DAYS. RECHARGE STATISTICS WERE NOT AVAILABLE. THE PATIENT CONTINUED TO RECEIVE GOOD THERAPEUTIC BENEFIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE133689N| STIM ACCESSORY: MODEL 37092, LOT# 219520001| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V247661014| LEAD: MODEL 3778, LOT# V267034014| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA131205N| IMPLANTED:| EXPLANTED: