BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202138 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00599
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    March 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT THIS WAS REPORTABLE EVENT. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT PAIN CONTROL SINCE THE PUMP WAS IMPLANTED. THE CALLER STATED THAT ¿SINCE IN (B)(6), NOTICED-THE PUMP WOULD DO DIFFERENT THINGS, LIKE, HE WOULD FEEL LIKE IT WOULDN¿T WORK FOR A COUPLE OF DAYS AND THEN ALL OF A SUDDEN HE WOULD FEEL LIKE HE WOULD GET, FEEL THE DRUG AMOUNT GO THROUGH,¿ THE PATIENT¿S SYMPTOMS WERE DIZZY, CONFUSED, AND MEMORY LOSS. THE PATIENT WOULD FEEL LIKE IT WASN¿T WORKING FOR A FEW DAYS, AND THEN HE WOULD FEEL THAT EFFECT AGAIN, TO THE POINT THAT IT GOT SEVERE HERE A COUPLE OF WEEKS AGO. THE PATIENT WAS CONSIDERING TO REMOVE THE SYSTEM. THE DRUGS DELIVERED IN THE SYSTEM WERE MORPHINE CLONIDINE BUPIVACAINE (MARCAINE) PRIALT OTHER. ADDITIONAL INFORMATION HAD BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303032 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1