BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3499598 · Received December 4, 2013

    Report

    Report Number
    3004209178-2013-21909
    Event Type
    Injury
    Date Received
    December 4, 2013
    Date of Event
    July 23, 2013
    Report Date
    November 15, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8575 LOT# N091113, IMPLANTED: 2007 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8709 LOT# L81595, IMPLANTED: 2000 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S PUMP WAS REPLACED IN (B)(6). PER THE PATIENT¿S FAMILY, THEY BELIEVED THAT IT WAS REPLACED BECAUSE, IT WASN¿T WORKING PROPERLY AS THE PATIENT JUST RECENTLY HAD A PUMP REPLACEMENT DUE TO REGULAR REPLACEMENT INTERVAL. THE PUMP WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627684 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention