BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3223069 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11670
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED VARIABLE AND INCREASED SPASTICITY. THE PHYSICIAN ATTEMPTED A CATHETER ASPIRATION WITHOUT SUCCESS AND NO FLUID WAS ABLE TO BE ASPIRATED. SURGERY WAS PERFORMED AND THE PUMP POCKET WAS OPENED. THE PUMP WAS REMOVED FROM THE POCKET SITE WHILE STILL CONNECTED TO THE CATHETER. CATHETER ASPIRATION FROM THE CATHETER ACCESS PORT WAS ACHIEVED WITHOUT RESISTANCE. THE CATHETER WAS CUT APPROXIMATELY 25 CM FROM PUMP/CATHETER CONNECTION. THE CEREBROSPINAL FLUID FLOW APPEARED UNIMPEDED. THE CATHETER WAS EXPLANTED AND REPLACED ON (B)(6) 2013 DUE TO A CATHETER ISSUE. THE PUMP WAS REMOVED AND APPROXIMATELY 30 MINUTES LATER THE AUDIBLE ALARM WAS HEARD. THE PUMP WAS INTERROGATED AND REVEALED TWO MOTOR STALLS WITH RECOVERY HAD OCCURRED. THE PUMP WAS INTERROGATED APPROXIMATELY 24 HOURS LATER AND NO ADDITIONAL LOGS HAD BEEN CREATED. THERE ARE NO LOGS INDICATING MOTOR STALLS OCCURRED WHILE THE PUMP WAS IMPLANTED. THE MOTOR STALL OCCURRED AFTER EXPLANTATION. THEY ELECTED TO REPLACE THE PUMP AS AN EFFORT TO ¿REPLACE ALL VARIABLE AND TO ELIMINATE THE NEED FOR REPLACEMENT¿ WITHIN 21 MONTHS (TIME OF ELECTIVE REPLACEMENT INDICATOR.) THE PATIENT WAS DOING WELL AND RECEIVING THERAPY. THE PUMP WAS DELIVERING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323602 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention