BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3944988 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13267
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703W, LOT# L50051, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS NOT HELPING THE PATIENT. THE HCP WAS WEANING THE PATIENT DOWN TO MIN RATE SO THE PUMP WAS GOING TO BE PROGRAMMED TO OFF STATE. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND DILAUDID. ADDITIONAL INFORMATION LATER REPORTED THE PATIENT EXPERIENCED INCREASED PAIN. THE CAUSE OF THE EVENT WAS INDICATED AS VERY HIGH RESIDUAL VOLUME INDICATING PUMP NOT PUMPING MEDICATION. TROUBLESHOOTING INCLUDED DECREASING DOSAGE. THE PUMP WAS SHUT OFF AND TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421698 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention