BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3852992 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10235
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. HOWEVER, A CATHETER ISSUE/OCCLUSION WAS REPORTED AS THERE WAS THE INABILITY TO ASPIRATE THE CATHETER VIA SIDE PORT. AT THE REFILL IT WAS INDICATED THAT THE EXPECTED RESERVOIR VOLUME (ERV) WAS 13 ML BUT THE ACTUAL RESERVOIR VOLUME (ARV) WAS 20 ML. THE LOCATION OF THE CATHETER ISSUE WAS NOT KNOWN NOR WAS THE CAUSE. A DYE AND ROLLER STUDY WERE ALSO PERFORMED. THE ISSUE WAS NOT RESOLVED AND A CATHETER REVISION WAS THE PLAN. AT THE TIME OF THE EVENT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED PRIALT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE REVISION WAS DONE SUCCESSFULLY. THE PUMP MANAGER REPORTED SATISFACTORY THERAPEUTIC RESULTS .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE ENTIRE CATHETER WAS REPLACED AND THE OLD CATHETER WAS LEFT IN PLACE. THE LOCATION OF THE ISSUE WAS NOT EXPLORED NOR WAS THE OCCLUSION CONFIRMED. THE PATIENT WAS DOING WELL NOW AFTER THE TOTAL CATHETER REPLACEMENT.

    Description of Event or Problem · 1

    THE CATHETER WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332813 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention