BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3811317 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08955
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 21, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL#(B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_PROG, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WENT THROUGH WITHDRAWAL A YEAR AGO AND WAS HURTING A LOT MORE. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) WAS BUSY AND THEY HAD NOT REPROGRAMMED IT ON THAT ¿FRIDAY.¿ IT WAS NOTED THAT THE ALARM STARTED GOING OFF ON ¿SATURDAY.¿ IT WAS NOTED THAT THE PATIENT HAD SPOKEN THE HCP AND THEY TOLD THE PATIENT, HE WOULD BE OKAY UNTIL ¿MONDAY MORNING.¿ IT WAS NOTED THAT THE PATIENT HAD GOTTEN THE REFILL BUT ¿THEY DIDN¿T REPROGRAM IT.¿ PATIENT STARTED TO GO THROUGH WITHDRAWAL. WHEN THE PATIENT WENT BACK ON THAT MONDAY, ¿EVERYTHING WAS FINE.¿ IT WAS NOTED THAT THE PUMP HELPS THE PATIENT. THE PUMP SYSTEM WAS DELIVERING BUPIVACAINE, BACLOFEN AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291139 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Other