BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 1202086 · Received October 16, 2008

    Report

    Report Number
    2182207-2008-06609
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS. USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID WAS OBSERVED LEAKING FROM AROUND A SC CATHETER CONNECTOR. THE HCP REPORTED THAT THE CONNECTOR WAS FULLY ATTACHED TO THE PUMP. NO PATENT SYMPTOMS OR IDENTIFIERS WERE REPORTED. UNABLE TO FOLLOW-UP WITH CONTACT INFORMATION PROVIDED, NO ADDITIONAL INFORMATION WAS OBTAINED.

    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 IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL 8709SC| EXPLANTED: