BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2933134 · Received January 29, 2013

    Report

    Report Number
    3004209178-2013-01075
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 4, 2013
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP HAD INVERTED AND THE PATIENT WAS ABLE TO ROTATE THE PUMP IN THE POCKET. ON (B)(6) 2012, THE PUMP WAS RE-SUTURED. IT WAS REPORTED THAT THE EVENT WAS RESOLVED WITHOUT SEQUELA. IT WAS UNCLEAR WHEN THIS EVENT TOOK PLACE AS THE RE-SUTURING REPORTEDLY TOOK PLACE IN 2012, BUT IT WAS REPORTED THAT THE EVENT WAS RESOLVED ON (B)(6) 2009. THE DRUG USED IN THIS SYSTEM WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES A VAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39108 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention