BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1833140 · Received September 9, 2010

    Report

    Report Number
    3004209178-2010-06918
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    November 1, 2009
    Report Date
    August 24, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATOR WAS NOT PROVIDING ANY PAIN RELIEF OR SYMPTOM REDUCTION. THE DEVICE WAS IMPLANTED IN THE RIGHT BUTTOCK IN (B)(6) 2009. THE PT STARTED HAVING PAIN BEHIND THAT AREA IN (B)(6) 2009, DEEP INSIDE. THE STIMULATOR WAS BULGING AND CAUSING PAIN AT THE IMPLANT SITE. THE PT FELT PAIN AT THE NEUROSTIMULATOR SITE, DOWN THE FRONT OF THE THIGH AND DOWN TO THE KNEE. THE SURGEON INDICATED IT COULD HAVE BEEN THE PIRIFORMIS MUSCLE. THE HCP REPROGRAMMED THE DEVICE WHICH DID NOT PROVIDE LASTING RELIEF. PHYSICAL THERAPY WAS NOT EFFECTIVE. THE PT WAS CONSIDERING DEVICE REMOVAL. IN (B)(6) 2010 THE PT HAD THE DEVICE REMOVED PERMANENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE129310N| EXPLANTED:| EXTENSION: MODEL 37082, LOT # NKB002076V| LEAD: MODEL 3998, LOT # V179180| LEAD: MODEL 3888, LOT # V230104| ACCESSORY: MODEL 37752, LOT # NKA127205N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT # V245999| EXPLANTED:| EXPLANTED:| IMPLANTED: