BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3962081 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13617
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOW RESERVOIR VOLUME REACHED ALARM OCCURRING WHICH WAS CONFIRMED BY TELEMETRY. THE PATIENT WAS IN THE EMERGENCY ROOM THE PREVIOUS NIGHT WITH INCREASED SPASMS. THE PUMP WAS ACCESSED AND ABOUT A DROP WAS GOTTEN BACK. THE SYSTEM WAS BEING USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437572 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR