BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4940251 · Received July 24, 2015

    Report

    Report Number
    3004209178-2015-14089
    Event Type
    Injury
    Date Received
    July 24, 2015
    Report Date
    July 1, 2015
    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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, LOT # N256712010, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 8703W, SERIAL # (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER; PRODUCT ID 8590-9, LOT # N253512, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS "UNDER THERAPEUTIC WITH BACLOFEN/SPASTICITY." THE CATHETER WAS SCHEDULED FOR EXPLORATION AND WHEN THE SPINAL AREA WAS EXPOSED, THE SPINE SEGMENT AND PUMP SECTION HAD A LEAK. THE HEALTHCARE PROFESSIONAL (HCP) IDENTIFIED IT AS "THE CONNECTION PIN HAVING POKED A PUMP SECTION HAD A LEAK." IT WAS ADDITIONALLY STATED, "THE PHYSICIAN IDENTIFIED IT AS THE CONNECTOR PIN HAVING POKED A CONNECTION WAS CUT AND REJOINING USING THE CLEAR/WHITE BOOTS AND NEW PIN." AN ADDITIONAL REPORTS STATES THERE WAS A CRACK IN THE CATHETER. THE CATHETER REVISION WAS COMPLETED ON (B)(6) 2015. THE PUMP WAS USED TO DELIVER GABLOFEN (BACLOFEN). THE OUTCOME OF THE EVENT WAS NOT REPORTED, BUT THE PATIENT'S STATUS WAS LISTED AS "ALIVE - NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483737 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Required Intervention