BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1800020 · Received August 12, 2010

    Report

    Report Number
    3004209178-2010-06060
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Report Date
    July 12, 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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PT EXPERIENCED INTERMITTENT SHOCKING. THE LEADS WERE BROKEN AND THE NEUROSTIMULATOR HAS NOT WORKED FOR SOME TIME. A NEW SYSTEM IS NEEDED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3986, LOT# NAM003085N| IMPLANTED:| EXTENSION: MODEL 7496-51, LOT# YR0013719N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3586, LOT# LW0015406N| PROGRAMMER: MODEL 7435, LOT# NFT006189P