BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1053255 · Received May 28, 2008

    Report

    Report Number
    2182207-2008-02847
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT EXPERIENCED INTERMITTENT THERAPY SINCE PUMP IMPLANT. THE PUMP POCKET WAS LOOSE AND THE PUMP WAS MOVING WITHIN IT. NO OTHER PT SYMPTOMS WERE REPORTED. IT WAS UNK IF THERE WERE ANY ALARMS; THE HCP HAD NOT CHECKED FOR VOLUME DISCREPANCIES. NO OTHER DIAGNOSTIC STUDIES WERE COMPLETED. THE HCP PLANNED TO REVISE THE PUMP. THE PUMP WAS USED TO ADMINISTER MORPHINE AND BUPIVACAINE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| CATHETER MODEL 8709SC LOT# N138060014 IMPLANTED: