BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3002469 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03658
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT PROGRAMMER MODEL 8835, SERIAL # (B)(4), IMPLANTED: NA, EXPLANTED: NA; CATHETER MODEL 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. COMPANY REPRESENTATIVE REPORTED THE ENTIRE CATHETER WAS REPLACED BECAUSE THE PATIENT WAS NOT GETTING GOOD THERAPY AND PAIN RELIEF. PATIENT LATER REPORTED THE PUMP WAS ALSO REPLACED ON (B)(6) 2013 BUT COMPANY REPRESENTATIVE CONFIRMED IT WAS ONLY THE CATHETER ON (B)(6) 2013. THE PATIENT DOSE WAS ADJUSTED THE DAY THIS INFORMATION WAS REPORTED. COMPANY REPRESENTATIVE REPORTED THE PATIENT WAS DOING WELL AFTER REPLACING THE CATHETER.

    Description of Event or Problem · 1

    CATHETER MIGRATED OUT OF INTRATHECAL SPACE, CONFIRMED WITH DYE STUDY IN (B)(6) 2012. REVISION NOT DONE UNTIL (B)(6) 2013 DUE TO SCHEDULING ISSUES. NO PATIENT SYMPTOMS WERE REPORTED. THE DEVICE SYSTEM WAS USED TO INFUSE DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105766 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Required Intervention