BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203097 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-06174
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    October 10, 2012
    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

    CONCOMITANT PRODUCTS: PATIENT PROGRAMMER MODEL 8835, SERIAL# (B)(4), IMPLANTED: NA; CATHETER MODEL 8709SC, LOT# N178302008, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERSONAL THERAPY MANAGER PROGRAMMER (PTM) WOULD NOT POWER ON THE DAY OF THE INITIAL REPORT. THE BATTERIES WERE CHANGED AND THE PTM TURNED ON. IT WAS THEN NOTED THAT THE REFILL DATE DISPLAYED ON THE PTM WAS NOT CORRECT. THERE WERE NO THERAPY ISSUES NOTED. THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL, HYDROMORPHONE, BUPIVACAINE, AND BACLOFEN (UNKNOWN). IT WAS LATER ADDED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY BUT THAT SHE WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301247 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR