BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3900012 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12191
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED THE HEALTH CARE PROVIDER (HCP) REGARDING HER REFILL AND WAS TOLD THE HCP NO LONGER REFILLS THE PUMPS BUT ONLY PROVIDES INJECTION. THE HCP HAD ONLY REFILLED HER PUMP ¿THE LAST TIME¿ AS A COURTESY AND THE PATIENT WAS NOT AWARE OF THIS ARRANGEMENT. THE PATIENT¿S LAST REFILL WAS (B)(6) 2014 AND ACCORDING TO HER PERSONAL THERAPY MANAGER (PTM) THE PUMP WOULD BE EMPTY ON (B)(6) 2014. THE PATIENT STATED, SHE WAS CONCERNED TO FIND A HEALTH CARE PROVIDER BEFORE HER PUMP RAN OUT AS THAT HAD HAPPENED TO HER ¿BEFORE.¿ IT WAS UNKNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. 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
    377376 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1