BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5053906 · Received September 3, 2015

    Report

    Report Number
    3004209178-2015-17264
    Event Type
    Injury
    Date Received
    September 3, 2015
    Report Date
    August 7, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE IS NOT APPLICABLE FOR THIS EVENT AND IS BEING REPLACED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER; PRODUCT ID 8590-1, LOT# N201184, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). ON (B)(6) 2015 THE HCP REPORTED THAT THEY ONLY STARTED SEEING THE PATIENT IN 2013. THE PATIENT HAD NO SYMPTOMS. A DYE STUDY WAS DONE ON (B)(6) 2015 TO ASSESS THE CATHETER. A NEW PUMP AND CATHETER WERE IMPLANTED ON (B)(6) 2015.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THROUGH A MANUFACTURING REPRESENTATIVE THAT THEY THOUGHT THE PUMP WAS OVERINFUSING IN 2013. THE PATIENT'S OUTCOME WAS UNKNOWN. THE CAUSE OF THE ISSUES WAS UNKNOWN. THE SYSTEM WAS DELIVERING CLONIDINE AND 160MCG/ML AND 57.76MCG/DAY, BUPIVACAINE AT 14MG/ML AND 5.05MG/DAY, AND MORPHINE AT 27MG/ML AND 9.758MG/DAY. THE LOT NUMBERS WERE UNKNOWN. THE INDICATIONS FOR USE WERE NON-MALIGNANT PAIN AND RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYNDROME. FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584010 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention