BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2010-17362

    MDR report key: 1872769 · Received October 18, 2010

    Report

    Report Number
    2124215-2010-17362
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 30, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT WAS MADE TO CONTACT THE AUTHOR OF THE ARTICLE TO DETERMINE WHETHER BOSTON SCIENTIFIC PRODUCTS WERE INVOLVED IN THE REPORTED ADVERSE EVENTS. ZUCCHELLI G, SOLDATI E, DI CORI A, DE LUCIA R, SEGRETI L, SOLARINO G, BORELLI G, DI BELLO V, BONGIORNI MG. ROLE OF INTRAOPERATIVE ELECTRICAL PARAMETERS IN PREDICTING REVERSE REMODELLING AFTER CARDIAC RESYNCHRONIZATION THERAPY AND CORRELATION WITH INTERVENTRICULAR MECHANICAL DYSSYNCHRONY. EUROPACE. 2010 JUL 27.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THROUGH REVIEW OF A JOURNAL ARTICLE THAT, IN A STUDY OF 86 HEART FAILURE PATIENTS, THREE SYSTEMS HAD A DISLODGEMENT OF THE LEFT VENTRICULAR (LV) LEAD. ALSO, TWO CASES OF POCKET HEMATOMA, ONE CASE OF PHRENIC NERVE STIMULATION, AND ONE CASE OF INAPPROPRIATE SHOCK WERE OBSERVED. TWO PATIENTS IN THE STUDY DIED DUE TO REFRACTORY HEART FAILURE. SEVENTY NINE PERCENT OF THE PATIENTS IN THE STUDY WERE IMPLANTED WITH BOSTON SCIENTIFIC H195 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death