BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202641 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-01410
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 20, 2012
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED THE PUMP WASN¿T WORKING AND NEVER HAVING THERAPEUTIC EFFECT. THE PATIENT WANTED THE PUMP EXPLANTED. THE PHYSICIAN WAS SWITCHING MEDICATION FROM FENTANYL TO MSO4 AND THE PATIENT HAD GONE THRU WITHDRAWAL. THE PATIENT WAS SICK AND LOST 30 LBS. THE REASON THAT THE PATIENT WAS DISMISSED ¿FAILURE TO HAVE IC PUMP REFILLE DIN A TIMELY FASHION MAY RESULT IN LIFE THREATENING WITHDRAWAL SYMPTOMS.¿ THE PATIENT HAD REALLY BAD ANXIETY DUE TO THE PUMP THE DOCTOR HAD PRESCRIBED 60 MG MORPHINE EXTENDED RELEASE /2 TIMES DAY FOR WHEN THE PUMP ALARMS. ALARM DATE WAS (B)(6) 2012. THE PATIENT STATED ¿HE WILL BE IN PAIN FOR REST OF HIS LIFE.¿ IT WAS NOTED THAT ¿THE PATIENT HAD EXISTING CONDITIONS OF CAUDA EQUINE AND ARACHNOIDITIS.¿ THE PATIENT WAS SCHEDULED PUMP EXPLANTED ON (B)(6) 2012 DUE TO PATIENT¿S CHOICE. MORPHINE SULFATE AND FENTANYL WERE USED IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301314 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention