BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3961089 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13580
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 5, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8781, SERIAL # (B)(6), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE SYMPTOMS RESOLVED SPONTANEOUSLY WITH NO MALFUNCTION OF THE PUMP SYSTEM DISCOVERED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON THE PUMP WAS STOPPED WAS BECAUSE THE CATHETER ACCESS PORT (CAP) WAS ACCESSED TO ASSESS CATHETER PATENCY. NO INTERVENTIONS WERE COMPLETED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INCREASED TONE. CATHETER ACCESS PORT (CAP) WITHDRAWAL WAS DONE AND 1 MILLILITER OF CLEAR FLUID WAS EASILY WITHDRAWN. THERE WAS A 9% INCREASE IN THE DOSE ON (B)(6) 2013-. IT WAS REPORTED THE SYSTEM WAS BEING USED TO DELIVER GABLOFEN AT THAT TIME. THE PUMP WAS IN STOPPED PUMP MODE ON (B)(6) 2014. THE PUMP WAS SHUT OFF FOR 22 MINUTES. THE PUMP WAS BEING USED TO DELIVER BACLOFEN AT THE TIME OF THE EVENT. IT WAS LATER REPORTED THE PATIENT HAD INTERMITTENT INCREASED TONE WITH MODERATE SEVERITY. THE EVENT WAS POSSIBLY RELATED TO THE CATHETER AND POSSIBLY RELATED TO THE IMPLANT PROCEDURE. THE EVENT WAS ONGOING AND NO ACTION HAD BEEN TAKEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439250 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00005 YR