BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1739284 · Received June 25, 2010

    Report

    Report Number
    3004209178-2010-05038
    Event Type
    Injury
    Date Received
    June 25, 2010
    Date of Event
    January 8, 2010
    Report Date
    June 1, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED INCREASED LOWER EXTREMITY PAIN. AN MRI WITH CONTRAST ON (B)(6) 2010, REVEALED "HNP". A CATHETER ACCESS PORT STUDY ON (B)(6) 2010, REVEALED A CATHETER LEAK. THE PUMP AND CATHETER WERE REPLACED. THE PUMP WAS EXPLANTED BECAUSE THE PUMP WAS 3 YEARS OLD. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention CATHETER: MODEL 8709, LOT# J11156R50.| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11156R50| EXPLANTED: