BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2120187 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04026
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    November 1, 2010
    Report Date
    May 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN NOVEMBER, A REVISION WAS DONE TO MOVE THE DEVICE UP DUE TO ABDOMINAL PAIN. THE PAIN IN THE ABDOMEN RADIATED DOWN TO THE GROIN AND INTO THE TESTICLE. THE PT INDICATED THE HEALTHCARE PROFESSIONAL THOUGHT THE DEVICE MAY HAVE BEEN LYING ON A NERVE. THE PT INDICATED IT HELPED THE PAIN FOR ONE DAY AND THEN THE PAIN RETURNED. FOLLOWING THE REVISION, THE PT WAS UNABLE TO HAVE A SHEET ON HIS STOMACH DUE TO THE PAIN. THE STIMULATION HELPED THE BACK PAIN AND THE PT DID NOT WANT TO TURN THE STIMULATION OFF. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 65 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE154181N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA144365N| LEAD: MODEL 39565-65, LOT# V522370018