BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2831462 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10235
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), CATHETER MODEL: 8598A, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INFLAMMATORY MASS. IT WAS CONFIRMED VIA A CT SCAN WHEN THE PATIENT PRESENTED TO THE ER WITH SYMPTOMS OVER THE PAST WEEKEND. THE HEALTHCARE PROVIDER (HCP) COULD NOT TELL IF THE "NEUROLOGICAL SYMPTOMS" WERE RELATED TO THE INFLAMMATORY MASS OR "SOMETHING ELSE". PATIENT ALSO COMPLAINED OF BACK PAIN. THE DRUGS DELIVERED VIA THE DEVICE WERE BUPIVACAINE AND DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other