BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800602 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08750
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 17, 2014
    Report Date
    April 16, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE CATHETER, PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT HAD A PUMP REPLACEMENT ON 2014-(B)(6), DUE TO TISSUE GROWING OVER THE CATHETER. IT WAS NOTED THAT THE PATIENT HAD MEMORY LOSS AND HAD A HARD TIME REMEMBERING. IT WAS NOTED THAT THE PUMP WAS MESSING UP AND PATIENT WAS NOT COMPLETELY SURE WHY. PATIENT DID NOT KNOW EXACTLY WHY THEY HAD THE PUMP REPLACED. THE MEDICATION INFUSING WAS UNKNOWN IN THE PUMP THAT WAS REPLACED. 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
    278549 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention