BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1872575 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07852
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE STOPPED WORKING. THE PT TURNED THE DEVICE OFF FOR A BRIEF TIME AND "NO JUICE" FLOWED WHEN HE WENT TO TURN IT BACK ON. THE PT REPORTED THAT HE DID NOT NEGLECT TO RECHARGE THE DEVICE. THE PT RECHARGED ONE TO TWO TIMES PER TWO WEEK PERIOD AND NEVER MISSED A SESSION. THE BATTERIES WERE REPLACED BUT THE PROGRAMMER INDICATED THERE WAS 2/3 CHARGE LEFT IN IT. THE PT EXPERIENCED THE FOLLOWING SYMPTOMS: SEVERE AND A FAST PROGRESSIVE AND UNTREATED, MEDICATION RESISTANT RHEUMATOID ARTHRITIS THAT INCLUDED 6 HERNIATED DISCS WITH STENOSIS; SPINAL FRACTURES; OSTEOARTHRITIS; OSTEOPOROSIS; CHRONIC PLEURISY; NEUROPATHY IN ALL FOUR LIMBS; SYSTEMIC JOINT SWELLING; SYSTEMIC LUPUS; CENTRAL NERVOUS SYSTEM LUPUS; DISCOID LUPUS; AND SJOGREN'S DISEASE. THE PT REPORTED THAT HIS HIGH LEVEL CONSTANT STIMULATION HELPED TO TAKE THE EDGE OFF OF THE LUMBAR REGION AND HIP AND LEG PAIN. ADD'L INFO HAS BEEN REQUESTED AND WILL BE MADE AS F/U AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR LEAD: MODEL 39565-65, LOT# N217251003| ACCESSORY: MODEL 37752, LOT# NKA130937N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE132559N| EXPLANTED:| IMPLANTED: