BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202730 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-06083
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    May 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8 709SC LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8590-1 LOT# N207294, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS PUMP WAS "LOOSE IN THE POCKET". IT WAS STATED IT¿S VERY DIFFICULT WHEN YOU HOLD A PATIENT'S PUMP STEADY THAT IS LOOSE IN THE POCKET WITH ONE HAND WHILE TRYING TO INSERT THE "FLIMSY" NEEDLE WITH THE OTHER HAND. ISSUE WAS NOTICED APPROXIMATELY 2-3 MONTHS AGO. THE PUMP WAS INFUSING HYDROMORPHONE (DILAUDID) AND BUPIVACAINE (MARCAINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301838 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR