BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3812329 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09017
    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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED CATHETER BODY HAS SIGNIFICANT TWISTING THAT MAY HAVE AFFECTED INFUSION. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS, INCLUDING A SLOW LOSS OF THERAPY EFFECTIVENESS. NO SUDDEN WITHDRAWAL WAS REPORTED. THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE CEREBROSPINAL FLUID (CSF) THROUGH THE CATHETER ACCESS PORT (CAP). A PARTIAL EXPLANT OF THE CATHETER WAS DONE ON (B)(6) 2014. THE CATHETER WAS TWISTED IN THE PUMP POCKET AND THE HCP WAS UNABLE TO ASPIRATE CSF. HE TRIMMED EXCESS CATHETER IN THE POCKET TO WHERE IT WAS TWISTED, REMOVED THE PUMP SEGMENT AND THEN ADDED A PUMP SEGMENT FROM THE REVISION KIT. THE SPINAL SEGMENT REMAINED INTACT. CSF FLOW WAS CONFIRMED BY THE HCP VIA THE CAP, AFTER HOOKING UP THE PUMP SEGMENT TO THE EXISTING PUMP AND AGAIN AFTER THE SUTURING OF THE PUMP TO THE POCKET. AT THE TIME OF THIS REPORT, THE PATIENT STATUS WAS INDICATED TO BE ¿ALIVE-NO INJURY.¿ THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291768 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention