BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2191980 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05694
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 28, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STIMULATION WAS TURNED ON, THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PT HAD IMPROVED WITH ADJUSTMENTS OF STIMULATION. THE HCP WAS CONSIDERING A LEAD REVISION.

    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 82 YR PROGRAMMER: MODEL 7435, LOT# NFT040408P| LEAD: MODEL 3888, LOT# L48647| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0044135N| EXPLANTED: