BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3033683 · Received April 3, 2013

    Report

    Report Number
    6000030-2013-00075
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J11189R37, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TO HAVE A MAGNETIC RESONANCE IMAGING (MRI) STUDY FOR A DIFFERENT HEALTH ISSUE. IT WAS NOTED THAT THE PATIENT WAS ON ORAL MEDICATIONS BECAUSE "THE BATTERY WAS REALLY LOW ON THE PUMP AND THEY DID NOT THINK IT WAS WORKING RIGHT." THE DRUG IN THE PUMP WAS NOT KNOWN. ADDITIONAL INFORMATION 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
    136354 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1