BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2032528 · Received March 24, 2011

    Report

    Report Number
    3007566237-2011-02249
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    November 23, 2010
    Report Date
    February 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CATHETER HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT HAD FREQUENT ISSUES WITH CATHETER BLOCKAGE LEADING TO WITHDRAWAL SYMPTOMS DESPITE REPLACEMENTS AND REVISIONS. THE CATHETER WAS REPLACED. THERE WAS REPORTED TO BE NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE 40 MG/ML AT 13.5 MG/DAY. ADD'L INFO HAS BEEN REQUESTED FOR INFO ABOUT THE PRIOR CATHETER REPLACEMENTS AND REVISION, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8598A, LOT # B0963398K| IMPLANTED:| EXPLANTED: