BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 4232357 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19546
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS AND LOSS OF CAPTURE AT MAXIMUM OUTPUTS. THE PHYSICIAN NOTED THAT THE AREA OF THE SUTURE SLEEVE APPEARED TO BE PINCHED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT DUE TO THE DAMAGED LEAD, THE PATIENT WAS REQUIRED FOR SURGERY. THE CAUSE WAS NOT CONCLUSIVELY DETERMINED. THE LV LEAD WAS EXPLANTED AND NO LONGER IN SERVICE WHILE THE CRT-D REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715116 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R N141| 4543| 4542| 0158| T175| 4136