BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2070155 · Received April 25, 2011

    Report

    Report Number
    3004209178-2011-03070
    Event Type
    Injury
    Date Received
    April 25, 2011
    Report Date
    April 6, 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
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED WITH NO INFO. ADDITIONAL INFO RECEIVED REPORTED THAT THE PT'S RIGHT LEAD MALFUNCTIONED. THE PT EXPERIENCED PRE-EXISTING PAIN. THE STIMULATION SYSTEM WAS EXPLANTED. THE PT RECOVERED WITHOUT SEQUELA.

    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 Male Required Intervention ACCESSORY: MODEL 37752, LOT# NKA020200N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V010773| LEAD: MODEL 3777, LOT# V011231| PROGRAMMER: MODEL 37742, LOT# NJD035132N| STIM ACCESSORY: MODEL 3550-39, LOT# UNK| STIM ACCESSORY: MODEL 3550-39, LOT# UNK| EXPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# UNK| LEAD: MODEL 3777, LOT# V010773| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD035132N| ACCESSORY: MODEL 37752, LOT# NKA020200N| EXPLANTED:| IMPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V011231| EXPLANTED: