BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3905263 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08531
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE DEVICE IS NOT EXPECTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE HOSPITAL FOLLOWING A SYNCOPAL EPISODE. REVIEW OF STORED ELECTROGRAMS (EGM) SHOWED INTERMITTENT NOISE, HOWEVER, NO OVERSENSING. TELEMETRY MONITORING IN THE HOSPITAL SHOWED OVERSENSING WITH PACING INHIBITION FOR GREATER THAN TWO SECONDS. THE PATIENT WAS PACEMAKER DEPENDENT. A SMALL AMOUNT OF NOISE WAS ABLE TO BE RECREATED. AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383215 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 1298| 4087| 4086