BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPORE

    MDR report key: 3920016 · Received July 8, 2014

    Report

    Report Number
    2124215-2014-13615
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    September 17, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE ENTIRE SYSTEM WAS LEFT IMPLANTED ON THE RIGHT SIDE AND A NEW PACEMAKER SYSTEM WAS IMPLANTED ON THE LEFT SIDE. DURING THE PROCEDURE THE RIGHT SIDED POCKET WAS NOT OPENED, INSTEAD THE PHYSICIAN OPTED TO REPROGRAM THE OUTPUTS FOR BOTH OF THE LEADS TO THEIR LOWEST VALUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CHRONIC RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED OVERSENSING OF NOISE. THE PATIENT EXPERIENCED SYNCOPE AND DIZZINESS DUE TO THE RV OVERSENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED PROGRAMMING AND SURGICAL OPTIONS DUE TO THE AGE OF THE LEADS. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. THE PRODUCTS REMAIN IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396487 BIOPORE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 431-04

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 431-04| 284-05| S603| 435-02| 1284