BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5067744 · Received September 10, 2015

    Report

    Report Number
    3007566237-2015-02554
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    August 13, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L74639, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. PRODUCT ID 8575, LOT# N131573, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED CATHETER BODY BROKEN. THE MOST PROXIMAL END OF THE CATHETER SEGMENT HAD A SLIGHT JAGGED LOOK TO IT ALONG WITH A SLIGHTLY OVAL SHAPE WHEN VIEWED IN CROSS SECTION. THIS INDICATED THE CATHETER MAY HAVE BEEN COMPRESSED AT THIS AREA AND MOST LIKELY BROKE AT THIS POINT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER (HCP), VIA A COMPANY REPRESENTATIVE, REGARDING A PATIENT WHO WAS RECEIVING LIORESAL INTRATHECAL (750 MCG/ML) AT 137 MCG/DAY VIA AN IMPLANTABLE PUMP. INDICATIONS FOR USE INCLUDED SPINAL CORD INJURY/SPINAL CORD DISEASE AND INTRACTABLE SPASTICITY. ON AN UNREPORTED DATE, A DYE STUDY WAS PERFORMED; THE RESULT WAS NOTED AS "FAILED." THERE WERE NO ASSOCIATED PATIENT SIGNS/SYMPTOMS REPORTED. ON (B)(6) 2015, THE PUMP AND CATHETER WERE REPLACED; THE PUMP WAS PROPHYLACTICALLY REPLACED TO AVOID IN-VIVO BATTERY DEPLETION, AS IT WAS AT 5 MONTHS TO ELECTIVE REPLACEMENT INDICATOR (ERI), AND WAS NOT RETURNED. AS OF (B)(6) 2015, THE PATIENT HAD RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION REGARDING THE DATES OF THERAPY AND LOT NUMBER OF THE LIORESAL, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, SYMPTOMS RELATED TO THE FAILED DYE STUDY, AND ANY ADDITIONAL TROUBLESHOOTING WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599487 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention