BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1844554 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07255
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 23, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION IN EITHER OF HIS LEGS. THERE WAS NO KNOWN RELATED ACCIDENT OR INCIDENT. IMPEDANCES WERE REPEATING THROUGH MOST BIPOLAR PAIRS AT 733, 843, 990, AND 1195 OHMS. A NEW SYSTEM WAS IMPLANTED ON (B)(6)2010. IT WAS UNCLEAR IF THE EXISTING SYSTEM WAS EXPLANTED. THE PT OUTCOME IS UNK. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME.

    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 69 YR Required Intervention IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU017417V| PROGRAMMER: MODEL 7435, LOT# NFT031030P| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT#NHU017416V| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0327076V| LEAD: MODEL 3487A, LOT# J0309614V