BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1230537 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07416
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    June 1, 2008
    Report Date
    October 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER KINK. NO PATIENT SYMPTOMS WERE REPORTED. THE REPORT INDICATED THAT THE CATHETER WAS SUCCESSFULLY REVISED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 IMPLANTED:| CATHETER: MODEL 8578| IMPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MDOEL 8709| EXPLANTED:| EXPLANTED: