BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4232198 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21077
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 17, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS TURNED OFF LAST MONTH BECAUSE THE MEDICATION WAS GOING INTO THE SOFT TISSUE AND NOT INTO THE SPINE. THE PUMP WAS GOING TO BE REMOVED NEXT WEEK; HOWEVER, THE CATHETER WAS NOT GOING TO BE EXPLANTED AS IT WAS TOO DANGEROUS. IT WAS NOTED THAT THE PUMP HAD NEVER WORKED SINCE IMPLANT AND THE CATHETER HAD DETACHED FROM THE SPINE THREE TIMES (SEE MANUFACTURER REPORT #3004209178-2014-21062 FOR THE FIRST TIME, MANUFACTURER REPORT #3004209178-2014-21065 FOR THE SECOND TIME, AND MANUFACTURER REPORT #3004209178-2014-21068 FOR THE THIRD TIME.) THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. THE SPECIFIC SYMPTOMS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712996 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention