BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2880411 · Received December 19, 2012

    Report

    Report Number
    3004209178-2012-12066
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 19, 2012
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF PAIN RELIEF. A CATHETER DYE STUDY INDICATED THAT THERE WAS A CATHETER KINK AT THE PROXIMAL SEGMENT, AND THE "CATHETER PLACEMENT WAS INACCURATE." THE PUMP WAS ALSO FLIPPED. THE PATIENT HAD BOTH THE PUMP AND CATHETER REPLACED. THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT, BUT NO PATIENT INJURY WAS REPORTED. THE DRUGS USED WITHIN THE PUMP WERE FENTANYL, BUPIVACAINE, AND PRIALT. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R