BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1230566 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07459
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REMOVED, DUE TO A POCKET INFECTION. NO PT SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. PER THE MFR'S DEVICE TRACKING SYSTEM, THE PT UNDERWENT A NEW PUMP REPLACEMENT IN 2008

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

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