BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1910988 · Received November 23, 2010

    Report

    Report Number
    3004209178-2010-09895
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 15, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT COMPLAINED OF PAIN AND DISCOMFORT AT THE IMPLANTABLE NEUROSTIMULATOR BUTTOCK SITES. ONE OF THE LEADS WAS PRODUCING UNCOMFORTABLE STIMULATION. BOTH NEUROSTIMULATORS WERE REPOSITIONED TO THE FRONT OF THE PT'S BODY USING NEW EXTENSIONS. THE BOTHERSOME LEAD WAS REPLACED. REFERENCE MFG REPORT # 3004209178201009896. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 68 YR Required Intervention EXPLANTED:| LEAD: MODEL 3888, LOT# V546741| IMPLANTED:| LEAD: MODEL 3888, LOT# V546741| LEAD: MODEL 3888, LOT# V543661| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LOT# NJK716371H| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V559295| ACCESSORY: MODEL 37752, LOT# NKA146207N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB007950V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V571323010| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V559295| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA146562N| PROGRAMMER: MODEL 37743, LOT# NKE158001N| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB006913V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V546741| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37713| EXTENSION: MODEL 37082, LOT# NKB007949V