BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2940230 · Received February 2, 2013

    Report

    Report Number
    3004209178-2013-01237
    Event Type
    Injury
    Date Received
    February 2, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN HEARING A CRITICAL ALARM OVER THE WEEKEND AND PRESENTED TO THE CLINIC WITH SYMPTOMS OF WITHDRAWAL. THE PUMP WAS INTERROGATED AND IT WAS FOUND THAT THE PUMP WENT INTO SAFE STATE ON (B)(6). NO OTHER EVENTS WERE IN THE EVENT LOGS SINCE THE LAST REFILL IN (B)(6). THE PUMP WAS REPROGRAMMED TO 100 MCG/DAY WITH A 25 MCG BOLUS. THE PUMP WAS PREVIOUSLY PROGRAMMED TO 175 MCG/DAY. THE PATIENT WAS KEPT IN THE CLINIC FOR AN HOUR AND APPEARED TO BE IMPROVING. THE PATIENT THEN BEGAN TO FEEL NAUSEOUS, SHORT OF BREATH AND ANXIOUS AND WAS SENT TO THE EMERGENCY ROOM. ALL OF THE SCREENING TESTS WERE FINE. THE PATIENT WAS TO BE DISCHARGED IN GOOD CONDITION. THE CAUSE OF THE EVENT WAS UNKNOWN; THE PATIENT DID NOT HAVE ANY MAGNETIC RESONANCE IMAGING. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN (BACLOFEN) AT 2000 MCG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45547 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization