BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1844834 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07245
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 17, 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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL. PATIENT FELL AND HIT HIS HEAD. PATIENT STATED THAT STIM HAD NOT BEEN WORKING SINCE THE FALL. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    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 73 YR EXTENSION: MODEL 7489, LOT# NHU103703V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3999, LOT# J0546562V| PROGRAMMER: MODEL 7435, LOT# NFT067550P| EXTENSION: MODEL 7489, LOT# NHU103706V