BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3803136 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08824
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L75111, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE PRIOR YEAR, THE PATIENT HAD A BOWEL OBSTRUCTION AND, AT THE TIME OF REPORT, HAD A STENOSIS IN THE NECK. THE PATIENT WAS GIVEN SO MUCH PAIN MEDICATION THAT SHE WENT THROUGH WITHDRAWAL FOR A MONTH TO ¿GET IT OUT¿. AT THE TIME OF REPORT, THE PATIENT WAS NOT ON ANY ORAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281381 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention