BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3032737 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04526
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    February 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8598A LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TOO MUCH MORPHINE IN HER PUMP (BACLOFEN/MORPHINE COMBINATION) AND THE PATIENT APPEARED TO BE SHOWING SIGNS OF BEING "NARCED OUT." THE PHYSICIAN WAS GOING TO PERFORM A PUMP EMPTYING PROCEDURE WITH OUR CATHETER ACCESS PORT (CAP) KIT. IT WAS NOTED THAT THE PATIENT WOULD THEN BE RECEIVING ONLY LIORESAL THROUGH HER PUMP. NO OTHER INTERVENTIONS WERE PERFORMED AND THE PATIENT STATUS WAS UNKNOWN AT THAT TIME. ADDITIONAL INFORMATION WAS PROVIDED THAT THE NARCOTIC OVERDOSE WAS LIKELY SECONDARY TO A COMBINATION OF INTRATHECAL MORPHINE WITH ORAL DILAUDID. THERE WAS A DOSE ADJUSTMENT ON (B)(6) 2013. THE PATIENT EXPERIENCED SEDATION AND RESPIRATORY DEPRESSION AND REQUIRED HOSPITALIZATION. THE PATIENT OUTCOME WAS REPORTED TO BE NON-SERIOUS INJURY/ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136678 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization| R