BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1021178 · Received March 28, 2008

    Report

    Report Number
    3004209178-2008-01692
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED:| CATHETER MODEL 8731SC LOT# N108789011