BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2230446 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06327
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 14, 2011
    Report Date
    October 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT SUFFERED DISCOMFORT TO THE PULSE GENERATOR SITE. AN INTERVENTION TOOK PLACE AND THE DEVICE WAS EXPLANTED ON (B)(6)-2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRESTORE RECHARGABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL BOOT, LOT# UNK| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V043917| IMPLANTED:| STIM ACCESSORY: MODEL BOOT, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL BOOT, LOT# UNK| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL BOOT, LOT# UNK| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# V037174| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA034342N| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD055158N| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB010852N| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB010511N| LEAD: MODEL 3487A, LOT# V055387| LEAD: MODEL 3487A, LOT# V044819| EXPLANTED:| EXPLANTED:| EXPLANTED: