BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2202293 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06106
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    AN END-OF-SERVICE/END-OF-LIFE MESSAGE WAS REPORTED AND APPEARED TO BE PREMATURE BATTERY DEPLETION. IMPEDANCES WERE WITHIN THE RANGE OF 873-1553 OHMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU125407V| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU124003V| PROGRAMMER: MODEL 7435, LOT# NFT059561P| LEAD: MODEL 3998, LOT# V007729| IMPLANTED:| IMPLANTED: