BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3033593 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04568
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PUMP REFILLED TWO DAYS AGO AND FELT THE PUMP HAD NOT BEEN WORKING SINCE THE REFILL. THE PATIENT HAD BEEN IN A LOT OF PAIN SINCE THE REFILL AND WAS HOSPITALIZED. A SESSION REPORT FROM THE REFILL SHOWED THAT THE PUMP WAS IN SIMPLE CONTINUOUS MODE DELIVERING 1.6 MG/DAY. THE PUMP SYSTEM WAS BEING USED TO DELIVER MORPHINE. 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
    136012 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization