BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1220417 · Received November 4, 2008

    Report

    Report Number
    3004209178-2008-07178
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S PUMP ERODED A THIRD TIME. THE PUMP WAS RELOCATED AND A MESH POUCH WAS ADDED TO TRY TO PREVENT FURTHER EROSION. REFERENCE MFR REPORT #'S 3004209178-2008-07171, 3004209178-2008-07173, 3004209178-2008-07180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER: MODEL 8709| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840| IMPLANTED: