BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 1871892 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17308
    Date Received
    October 16, 2010
    Report Date
    September 9, 2010
    Product Code
    NVN
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS LEAD WAS NOT RETURNED FOR ANALYSIS, BOSTON SCIENTIFIC CRM CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ACCORDING TO AVAILABLE INFORMATION, A REVISION PROCEDURE WAS PERFORMED, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD REPORTED EXPERIENCING DIZZINESS AND LIGHT HEADEDNESS SYMPTOMS. INTERROGATION REVEALED THIS LEAD DISPLAYED A HIGH OUT OF RANGE IMPEDANCE MEASUREMENT. A REVIEW OF THE ELECTROGRAMS REVEALED VENTRICULAR TACHYCARDIA AND ATRIAL TACHYCARDIA RESPONSE EPISODES HAD OCCURRED. IN ADDITION, NOISE WAS DISPLAYED. NORMAL THRESHOLD MEASUREMENTS WERE OBTAINED. THE PATIENT WITH THIS LEAD WAS REFERRED TO A SURGEON FOR A POSSIBLE LEAD REVISION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1