BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4243404 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21313
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 22, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 85 96SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    DURING THE CATHETER REVISION ON (B)(6) 2014, THE PUMP SEGMENT OF THE CATHETER WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS ALONG WITH INCREASED SPASTICITY IN HER EXTREMITIES, TIGHTNESS, ITCHING, AND IRRITABILITY. THE HEALTHCARE PROVIDER WAS TO PRESCRIBE VALIUM FOR THE PATIENT. THE PUMP HAD A VOLUME DISCREPANCY. A GREATER THAN EXPECTED RESERVOIR VOLUME WAS FOUND AT ROUTINE REFILL THREE MONTHS PRIOR (APPROXIMATELY 10 ML ACTUAL VOLUME VERSUS THE EXPECTED VOLUME OF 4 ML), THEN AGAIN AT A REFILL ON (B)(6) 2014 (VOLUMES UNKNOWN). THE CAUSE OF THE DISCREPANCY WAS UNKNOWN. A CATHETER DYE STUDY HAD BEEN PERFORMED (DATE NOT PROVIDED) AND WAS NEGATIVE. A CATHETER OBSTRUCTION OF FLOW WAS SUSPECTED DUE TO THE HIGHER THAN EXPECTED RESERVOIR VOLUME, THE CAUSE AND LOCATION WERE UNKNOWN. ON (B)(6) 2014 A CATHETER ASPIRATION WAS ATTEMPTED VIA THE CATHETER ACCESS PORT AND IT WAS NOT POSSIBLE TO OBTAIN ANY CEREBROSPINAL FLUID (CSF) PRE-OPERATIVELY OR INTRA-OPERATIVELY. A REVISION WAS PERFORMED AND THE CATHETER WAS REPLACED. NO DEFECT WAS ABLE TO BE CLEARLY IDENTIFIED, ALTHOUGH SUTURE LESS PUMP CONNECTOR WAS DIFFICULT TO REMOVE FROM THE CATHETER PORT. PRIOR TO REMOVAL FROM PUMP, SC WAS ABLE TO BE ROTATED FREELY AND REMAINED INTACT WHEN PULLED ON. ONCE REMOVED FROM PUMP, THE 8596SC WAS ABLE TO BE FLUSHED EASILY FROM POCKET TO SPINE. THE CATHETER WAS DISCARDED BY THE CUSTOMER. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY¿. THE PUMP WAS DELIVERING COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726194 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention