BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4516342 · Received February 13, 2015

    Report

    Report Number
    3004209178-2015-02984
    Event Type
    Injury
    Date Received
    February 13, 2015
    Report Date
    January 20, 2015
    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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL COMPLAINING OF PAIN, NAUSEA, VOMITING, AND CHILLS. THE SYMPTOMS WERE CONSISTENT WITH DRUG WITHDRAWAL SYMPTOMS. IT WAS NOTED THAT DUE TO A PUMP MALFUNCTION, THE PATIENT WENT THROUGH MORPHINE WITHDRAWAL. THE PATIENT RECEIVED NO WARNING THAT THE PUMP NO LONGER HAD MORPHINE IN IT. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013, TO HAVE THE PUMP REMOVED AND REPLACED. IT WAS NOTED THAT AS A RESULT OF THE PUMP MALFUNCTION THE PATIENT SUFFERED PERMANENT INJURIES, PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT AND DISABILITY. IT WAS ALLEGED BY AN ATTORNEY, THAT THE MANUFACTURER FAILED TO PERFORM ADEQUATE TESTING, EVALUATIONS IN THE DESIGN, MANUFACTURE, TESTING, MARKETING, DISTRIBUTION, TESTING AND PLACEMENT OF THE PUMP INTO THE STREAM OF COMMERCE. IT WAS FURTHER ALLEGED BY AN ATTORNEY, THAT AT THE TIME OF THE DESIGN, MANUFACTURE AND SALE OF THE PAIN PUMP, A SAFER ALTERNATIVE DESIGN WAS AVAILABLE THAT WOULD HAVE PREVENTED OR SIGNIFICANTLY REDUCED THE RISK INVOLVED WITHOUT SUBSTANTIALLY IMPAIRING THE PUMP¿S UTILITY AND SUCH SAFER ALTERNATIVE DESIGN WAS ECONOMICALLY AND TECHNOLOGICALLY FEASIBLE AT THE TIME THE PAIN PUMP LEFT THE CONTROL OF MANUFACTURER. IT WAS NOTED THAT PAIN PUMP SOLD TO PATIENT WAS DEFECTIVE IN ITS DESIGN WHEN IT LEFT THE HANDS OF THE MANUFACTURER AND WAS UNREASONABLY DANGEROUS. IT WAS ALLEGED THAT THE PAIN PUMP DEVIATED FROM PRODUCT SPECIFICATIONS, POSING A SERIOUS RISK THAT THE PAIN PUMP WOULD FAIL TO ALERT THE USER THAT THERE WAS NO MORE PAIN MEDICATION WITHIN THE PUMP. THE PUMP WAS SUED TO INFUSE MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107604 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R| S