BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3905602 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11688
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WITH THIS DEVICE SYSTEM ENDURED A SYNCOPAL EVENT AND WAS PRESENTED WITH A HEART RATE IN THE 30BPM RANGE. UPON FURTHER REVIEW, OVERSENSING AND LOSS OF CAPTURE (LOC) WAS NOTED. RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS WERE BELOW 100 OHMS. WHEN PROGRAMMED TO UNIPOLAR SETTINGS, CAPTURE WAS OBSERVED WITH IMPEDANCE MEASUREMENTS OF 200 OHMS. THE PHYSICIAN SUSPECTED THE CAUSE TO BE A RESULT OF A POSSIBLE INSULATION BREAK. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383947 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 5076| 4136| K173| 4469| S606