BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1083471 · Received July 29, 2008

    Report

    Report Number
    3004209178-2008-04473
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 3, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD AND EXTENSION WERE RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAK. THE PATIENT WAS UNABLE TO TOLERATE THE THERAPY WHILE THE DEVICE WAS ON BECAUSE OF "TIGHTENING" SYMPTOMS FOLLOWING A LEAD REVISION IN 2008. THE PATIENT WAS UNABLE TO TOLERATE STIMULATION AT .10 VOLTS. THE PATIENT NEVER TURNED OFF THE DEVICE SINCE THE REVISION, REASON UNKNOWN. IMPEDANCE MEASUREMENTS WERE 2093 OHMS. THE LEAD AND EXTENSION WERE REVISED/REPLACED IN THE FOLLOWING MONTH. NO TIGHTNESS WAS REPORTED WITH INTRA-OPERATIVE TESTING. REFER TO MANUFACTURER REPORT # 3004209178200803856 FOR ADDITIONAL INFORMATION PRECEDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU068732V| EXPLANTED:| IMPLANTED:| LEAD MODEL 3887 LOT# V115220