BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3120772 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07928
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N223748, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED THAT A PATIENT STATED THEIR PTM WAS NOT WORKING; THAT IT WAS DISPLAYING A DATE OF (B)(6). IT WAS FURTHER NOTED THAT THE PATIENT WAS GIVEN A NEW PTM THREE DAYS PRIOR TO THE REPORT. IT WAS THOUGHT THAT THE PATIENT NEEDED TO DECOUPLE AND RECOUPLE THEIR PTM. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN. THE FOLLOWING DAY, THE PATIENT REPORTED THAT HIS PTM WAS NOT WORKING; THAT WHEN HE REQUESTED A BOLUS A ¿ONE AND THEN AN EIGHT, AND THEN AN X, AND THE NUMBER 8621¿ WAS DISPLAYED ON THE SCREEN. THE REFILL DATE WAS NOTED TO STILL DISPLAY (B)(6). IT WAS THOUGHT THAT THE PTM WAS NOT COUPLED TO THE PATIENT¿S PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221874 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1