BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4925874 · Received July 20, 2015

    Report

    Report Number
    3004209178-2015-13694
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, LOT# N179043011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(4)2015, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS BEING REPLACED DUE TO NORMAL BATTERY LONGEVITY. WHEN THE PHYSICIAN REMOVED THE PUMP FROM THE POCKET, HE ACCIDENTLY CUT THE CATHETER. THE PUMP SEGMENT OF CATHETER WAS REVISED. AFTER THE REVISION, THE PHYSICIAN WAS UNABLE TO ASPIRATE ANY FLUID FROM THE CATHETER. THE PHYSICIAN WAS ATTEMPTING TO ASPIRATE FROM THE CATHETER CONNECTOR. ACCESSING THE CAP (CATHETER ACCESS PORT) WAS DISCUSSED; IF UNSUCCESSFUL THEY WOULD EVALUATE FURTHER. THE PUMP WAS REPLACED AND A PRIMING BOLUS OF THE INTERNAL PUMP TUBING PLUS 66CM FOR THE NEW PUMP SEGMENT OF CATHETER WAS COMPLETED PRIOR TO CONNECTING TO THE NON-ASPIRATED PORTION OF THE CATHETER. THE PATIENT HAD NO SYMPTOMS RELATED TO THE EVENT. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470354 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR