BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2191029 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-05557
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION WHILE TRYING TO RECHARGE. IT WAS NOTED THAT THE EXTERNAL RECHARGER PADDLE COMPONENT HAD WORN AWAY AND THE WIRES BECAME EXPOSED. THE PATIENT WAS ISSUED A NEW EXTERNAL RECHARGER UNIT. ADDITIONAL INFORMATION WAS REQUESTED.

    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 44 YR PROGRAMMER: MODEL 37742, LOT# NJD059050N| EXTENSION: MODEL 37083, LOT# NKA026334N| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37791, LOT# UNKNOWN| LEAD: MODEL 3998, LOT# V013615| ACCESSORY: MODEL 37752, LOT# NKA026334N| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC010277N| IMPLANTED: