BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1052564 · Received May 22, 2008

    Report

    Report Number
    2182207-2008-02743
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1147-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. THE SERIAL NUMBER IS INCLUDED IN THE RANGE OF THE SYNCHROMED EL PUMP FOR POSSIBLE INFLAMMATORY MASS. AN URGENT MEDICAL DEVICE CORRECTION LETTER WAS SENT JANUARY 16, 2008, TO HEALTH CARE PROFESSIONALS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP AND CATHETER WERE REPLACED; NO PATIENT SYMPTOMS PRIOR TO REPLACEMENT WERE REPORTED. THE DEVICES WERE RETURNED FOR ANALYSIS AND IT WAS REQUESTED THAT THE CATHETER TIP BE EXAMINED FOR "POSSIBLE GRANULOMA" AS THE HCP WAS UNCERTAIN IF THERE WAS A CATHETER ISSUE. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION 8703W L44304

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention EXPLANTED| PUMP MODEL #862718| PROGRAMMER MODEL PROGRAMMER