BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 1871925 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17516
    Date Received
    October 16, 2010
    Report Date
    September 15, 2010
    Product Code
    NVN
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD PASSED CONDUCTOR RESISTANCE, HIGH POTENTIAL, AND INSULATION PRESSURE TESTING, CONFIRMING BOTH THE CONDUCTOR AND INSULATION WERE UNCOMPROMISED. ANALYSIS WAS UNABLE TO REFUTE THE ALLEGATION OF DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH SYMPTOMS OF TIREDNESS AND A GENERAL LACK OF ENERGY. A SYSTEM CHECK FOUND THE ATRIAL LEAD EXHIBITED HIGH THRESHOLDS AND LOSS OF CAPTURE (LOC). AN X-RAY CONFIRMED THE LEAD HAD DISLODGED. IN A REVISION PROCEDURE, THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED BY A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE LEAD NVN

    Patients

    Seq Age Sex Outcome Treatment
    1 4479| 4469| S603| 4456