BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3233655 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11958
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT# L59326, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACTUAL RESIDUAL VOLUME (14 ML) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (2 ML). THIS WAS NOT THE FIRST REFILL OF THE PUMP. THERE WAS NO THERAPY OR MEDICAL PROBLEM; THE PATIENT DID NOT REPORT ANY CHANGE IN SYMPTOMS. THE PUMP WAS DELIVERING DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334862 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR