BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1180924 · Received September 23, 2008

    Report

    Report Number
    3004209178-2008-06047
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Report Date
    August 27, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED AN UNSPECIFIED CHANGE IN THERAPY EFFECT. PUMP VOLUME DISCREPANCIES WERE NOTED AT REFILL VISITS. AT THE MOST RECENT REFILL VISIT, THE EXPECTED RESERVOIR VOLUME WAS 3 MLS WHILE THE ACTUAL VOLUME WAS 26 MLS; THE VOLUMES FOR PRIOR REFILL VISITS WERE NOT PROVIDED. THE PATIENT WAS BEING SUPPLEMENTED WITH ORAL BACLOFEN; THE PATIENT HAD NEVER HAD GREAT CONTROL AND IT WAS THOUGHT THAT THE PATIENT HAD ALWAYS BEEN TAKING ORAL BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTH CARE PROFESSIONAL, 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 EXPLANTED:| CATHETER:MODEL 8709SC| CATHETER:MODEL 8709| CATHETER:MODEL 8575| EXPLANTED:| PROGAMMER: MODEL PROGRAMMER| EXPLANTED: