BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-19447

    MDR report key: 1944836 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19447
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMAITON BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION PERTAINING TO A STUDY DONE TO EXPLORE THE LONG TERM RELIABILITY AND CAUSES OF LONG TERM SENSING FAILURE OF VDD SYSTEMS. A TOTAL OF 157 PATIENT WERE ENROLLED IN THE STUDY. DURING THE FOLLOW UP PERIOD, THREE PATIENT UNDERWENT A REVISION OF THEIR VDD LEAD FOR DIFFERENT REASONS, ONE FOR A RIGHT ATRIAL LEAD DISLODGMENT AND TWO FOR RIGHT ATRIAL LEAD FRACTURES. IN ADDITION, A SYMPTOMATIC FAILURE OF THE VDD PACING MODE WAS DETERMINED IN SEVEN PATIENTS DUE TO INAPPROPRIATE ATRIAL SENSING. THE THREE BRADYCARDIA LEADS REFERENCED ARE INTERMEDICS UNITY (MODEL 292-07); UNIPASS LEAD (MODEL 425-04); UNIPASS LEAD (MODEL 426-33). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1