BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1932035 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10043
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT SAW THE IMPLANTING HCP WHO GAVE THE PT A PRESCRIPTION FOR A BINDER TO WEAR TO HELP THE PUMP STAY IN PLACE. THE PUMP WAS "MOVING AROUND TOO MUCH." ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF 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., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N260356003| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG018283N