BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4111288 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17574
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER FOUND CORING AND TEARS IN THE SEAL OF THE CONNECTOR. THE CONNECTOR WAS LEAKING DUE TO THE TEARS. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8578, LOT# N130637, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS FILLING/ASPIRATION DIFFICULTIES, SPECIFIED AS THEY WERE UNABLE TO WITHDRAWAL CSF FROM THE CATHETER DURING A BATTERY CHANGE. THE CATHETER WAS REMOVED AND CSF FLOWED. THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED A REPLACEMENT. DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT REQUIRED. AT THE TIME OF REPORTED THAT PATIENT¿S STATUS WAS ALIVE ¿ NO INJURY. THERE WERE NO SYMPTOMS ASSOCIATED WITH THE EVENT. THE PUMP WAS USED TO INFUSE COMPOUNDED BACLOFEN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590712 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR