BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1181747 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06215
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PUMP HAD LESS VOLUME THAN EXPECTED. THE EXPECTED RESERVOIR VOLUME WAS 6.8 MLS; THE ACTUAL VOLUME WAS 0 MLS. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. 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. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR EXPLANTED:| CATHETER: MODEL 8711| PROGRAMMER: MODEL 8840