BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1211063 · Received October 24, 2008

    Report

    Report Number
    3004209178-2008-06850
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    September 25, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S INTRATHECAL DRUG DELIVERY PUMP HAD FLIPPED IN THE POCKET. THE CATHETER WAS DISLODGED FROM THE PUMP AND KINKED IN TWO PLACES. NO INFORMATION WAS PROVIDED ON HOW THE EVENTS WERE CONFIRMED. IT WAS ALSO REPORTED THE PT HAD BOWEL SURGERY AND HAD DRAINAGE TUBES ON BOTH SIDES OF HER ABDOMEN. IT WAS UNKNOWN IF/ WHEN THE TUBES WERE PULLED OUT; IT MIGHT HAVE PULLED ON THE CATHETER. THE PUMP HAD BEEN STOPPED. A REVISION WAS PLANNED FOR 2008. NO PT SYMPTOMS WERE REPORTED. THE DRUG USED IN THE PUMP WAS UNKNOWN. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    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:| PROGRAMMER MODEL 8840| EXPLANTED:| CATHETER MODEL 8711