BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 4131711 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14921
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    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 PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF DIZZINESS, SYNCOPE AND A LOW HEART RATE IN THE 30 BEAT PER MINUTE RANGE. UPON INTERROGATION IT WAS FOUND THAT THERE WAS INCREASED THRESHOLD MEASUREMENTS WITH INTERMITTENT RIGHT VENTRICULAR (RV) CAPTURE. A TEMPORARY PACING WIRE WAS PLACED AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. THE FOLLOWING DAY A REVISION PROCEDURE WAS PERFORMED WHERE ANOTHER MANUFACTURER'S RV LEAD WAS SURGICALLY ABANDONED. THE CAUSE OF THE INTERMITTENT LOSS OF CAPTURE WAS UNKNOWN AS THERE WERE NO SIGNIFICANT FINDINGS UNDER FLUOROSCOPY. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612176 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R E143| T180| 4471| 6949| 4470| MISMATCH| 1291