BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3230242 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11865
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    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 THAT THE PUMP ALARMED FOR A LOW RESERVOIR ON THE DAY OF REPORT. THE RESERVOIR CONTAINED 1.8CC, BUT THE PATIENT HAD NOT EXPERIENCED ANY SYMPTOMS OF WITHDRAWAL. AT THAT TIME OF REPORT, THE PUMP WAS BEING REFILLED AND REPROGRAMMED. SEVEN WEEKS LATER, IT WAS REPORTED THAT THE EVENT HAD BEEN CAUSED BY A DELAY IN THE REFILL. THERE WAS NO HOSPITALIZATION REQUIRED AND NO PATIENT SYMPTOMS OR INJURIES. THE PATIENT HAD BEEN COUNSELED TO RETURN FOR HIS NEXT REFILL ON THE SCHEDULED DATE. IT WAS UNCLEAR WHICH DRUG WAS USED IN THE PUMP. AT FIRST, IT WAS STATED THAT THE LIORESAL WAS USED AND LATER WAS STATED THAT GABLOFEN WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328592 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1