BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3895335 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12061
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD SYMPTOMS OF "ALTERED MENTAL STATUS - DELIRIUM" AND "RETURN OF PATIENT SYMPTOMS - INCREASED SPASTICITY". OVER THE PAST 24 HOURS, THE HOSPITAL HAD GIVEN THE PATIENT 5 MG OF TID BACLOFEN AND SOME NARCOTIC BECAUSE THE PATIENT HAD INCREASED SPASTICITY AND TO PREVENT WITHDRAWAL. THE PATIENT STILL HAD ALTERED MENTAL STATUS AND SPASTICITY TODAY. THE HEALTHCARE PROFESSIONAL (HCP) DID NOT THINK THE PUMP WAS ALARMING CURRENTLY. IT WAS NOTED THE PATIENT'S LAST PROGRAMMING WAS PERFORMED ON (B)(6) 2014 AND THEY THOUGHT THEY "MAY HAVE DECREASED THE DOSE BY 8% SINCE THEN". THE PUMP WAS USED TO INFUSE BACLOFEN AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371624 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| O