BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203130 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04813
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    October 29, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ON NARCOTICS FOR ALMOST 10 YEARS AND NO LONGER WANTED TO BE ON THEM. THE PATIENT HAD BEEN IN THE HOSPITAL FOR 4 DAYS IN (B)(6) 2012 FOR A FRACTURE IN HIS ARM. THE PATIENT WAS GIVEN NARCOTICS AT THAT TIME AND STATED HE WENT THROUGH WITHDRAWAL ONCE HE WAS DONE WAS THEM. THE PATIENT ALSO REPORTED THAT THERE WERE OTHER INSTANCES OF WITHDRAWAL FROM NARCOTICS WITHIN THE PAST 10 YEARS. THE PATIENT HAD THE MEDICATIONS REMOVED AND STOPPED REFILLING THE PUMP IN (B)(6) 2012 BECAUSE HE DID NOT FEEL IT WAS HELPING HIM. THE PUMP THEN BEGAN TO ALARM AND THE PUMP WAS TURNED OFF AND WAS ¿PERMANENTLY SILENCED¿ IN (B)(6) 2012. THE PATIENT CURRENTLY DID NOT HAVE MEDICATION IN THE PUMP AND DID NOT WANT TO HAVE NARCOTICS PUT IN THE PUMP. THE PATIENT CONSIDERED EITHER HAVING THE PUMP REMOVED OR FINDING A PHYSICIAN WHO WAS WILLING TO USE NON-NARCOTICS IN THE PUMP. PRIOR TO EMPTYING THE PUMP, THE DEVICE DELIVERED CLONIDINE, BACLOFEN, DILAUDID AND MORPHINE. PATIENT OUTCOME WAS NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301409 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Other