BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3964774 · Received July 29, 2014

    Report

    Report Number
    3004209178-2014-13630
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    April 18, 2012
    Report Date
    July 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8711, LOT # N086325035, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT DEVELOPED DYSPNEA AND THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND HOSPITALIZED. ON (B)(6), THE PATIENT HAD RESTRICTED BREATHING ACCOMPANYING THE INCREASED GABALON DOSAGE. THE INCREASED DOSAGE WAS THE SUSPECTED CAUSE WHEN THE PATIENT WAS CONSULTED BY THE PHYSICIAN. DURING HOSPITALIZATION THE PATIENT¿S DOSE WAS THEN REDUCED TO 80 MICROG/DAY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED RESPIRATORY DEPRESSION DUE TO THE INCREASED DOSAGE OF BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441577 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R