BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2190728 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-05790
    Event Type
    Injury
    Date Received
    July 26, 2011
    Report Date
    June 30, 2011
    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
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATOR WOULD ONLY CHARGE TO 25% AND WOULD DRAIN VERY QUICKLY. THE BATTERY HAD SHOWN A SLOW LOSS OF ABILITY TO HOLD A CHARGE. IMPEDANCES WERE WITHIN NORMAL LIMITS. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2011 DURING WHICH HIS NEUROSTIMULATOR AND LEADS WERE REPLACED. THE NEW PADDLE LEADS WERE PLACED HIGHER THAN THE PREVIOUS LEADS. THE PATIENT WAS RECEIVING GOOD RESULTS AND INCURRED NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| LEAD: MODEL 3778, LOT# V006680| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA022316N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V009508| PROGRAMMER: MODEL 37742, LOT# NJD030434N