BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4141081 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18306
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT AN MRI WITHOUT CONTRAST WAS PERFORMED ON (B)(6) 2014. IMAGING DID NOT REVEAL AN INFLAMMATORY MASS. THE CLINICAL DIAGNOSIS WAS INCREASED PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). ON (B)(6) 2014 THE PUMP DOSE WAS INCREASED 16% TO DELIVER DILAUDID 1.5686MG/DAY AND CLONIDINE 156.86MCG/DAY. A SINGLE BOLUS OF DILAUDID 0.1991MG AND CLONIDINE 19.91MCG WAS GIVEN AT THIS TIME WITH A DURATION OF 3 MINUTES. EVENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INCREASED PAIN WITH SUSPECTED INFLAMMATORY MASS. THE PATIENT REPORTED INCREASED BILATERAL HIP PAIN WITH A HISTORY OF AN INFLAMMATORY MASS. THE HEALTH CARE PROFESSIONAL ORDERED AN MRI AND AN X-RAY. THE X-RAY DID NOT REVEAL AN INFLAMMATORY MASS AND THE MRI HAD NOT YET BEEN PERFORMED. THE X-RAY RESULT ON (B)(6) 2014 WAS NORMAL FOR THIS PATIENT. IT WAS NOTED AS RELATED TO THE INTRATHECAL MEDICATION. THE SEVERITY WAS MILD (DOES NOT INTERFERE IN A SIGNIFICANT MANNER WITH THE SUBJECT¿S NORMAL FUNCTIONING LEVEL). THE EVENT WAS ON-GOING AS OF (B)(6) 2014. THE PUMP WAS USED TO INFUSE DILAUDID (4 MG/ML AT 1.3485 MG/DAY) AND CLONIDINE (400 MCG/ML AT 134.85 MCG/DAY). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618861 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other