BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRHOMED II

    MDR report key: 1243709 · Received November 25, 2008

    Report

    Report Number
    3004209178-2008-07738
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 28, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CATHETER HAD MIGRATED. THE CATHETER MIGRATION WAS NOTED BY FLUOROSCOPY IN 2008. THE CATHETER HAD SLIPPED FROM T10; THE TIP WAS NOTED TO BE NEAR L3. THE REMAINDER OF THE CATHETER HAD BEGUN TO COIL BEHIND THE PUMP. THE PATIENT LATER REPORTED THAT THE CATHETER MAY HAVE SLIPPED LOWER AS SHE HAD A LUMP ON HER LOWER BACK, AND THERE WAS BRUISING IN THE AREA. REVISION SURGERY WAS PLANNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention CATHETER: MODEL 8709SC| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840