BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3771410 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09145
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    September 4, 2012
    Report Date
    February 27, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS IN POSSESSION OF THE HOSPITAL. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD IMPEDANCE MEASUREMENT HAD INCREASED FROM 1200 OHMS AT THE RECENT CHANGE OUT PROCEDURE TO GREATER THAN 2000 OHMS. POSSIBLE LOSS OF ATRIAL CAPTURE AND A PROBLEM WITH THE ATRIAL SENSING WERE ALSO OBSERVED. IT WAS NOTED THAT AT THE RECENT CHANGE OUT PROCEDURE THE RA IMPEDANCE MEASUREMENTS WERE AT 1200 OHMS. THE PATIENT WAS SENT FOR A CHEST X-RAY AND RESULTS WERE NOT AVAILABLE FROM THE PHYSICIAN. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. THE RA LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAIN IMPLANTED. APPROXIMATELY FIVE AND A HALF YEARS LATER A REVISION PROCEDURE WAS PERFORMED WHERE THE RA LEAD AND CRT-D WERE EXPLANTED. IT WAS NOTED THAT THE RA LEAD WAS EXPLANTED IN PIECES. A LEAD FRACTURE IN THE CLAVICLE REGION WAS THE SUSPECTED CAUSE OF THE HIGH IMPEDANCE MEASUREMENTS, BUT IT WAS NOT CONFIRMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, RIGHT ATRIAL (RA) LEAD PACING IMPEDANCE MEASUREMENT WAS 1,200 OHMS, ULTIMATELY REACHING GREATER THAN 2,000 OHMS, WITH QUESTIONABLE ATRIAL CAPTURE. THE PATIENT WAS SENT FOR A CHEST XRAY AND RESULTS WERE NOT AVAILABLE FROM THE PHYSICIAN. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248815 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 0296| S606| N140| 4136| 4555| 4135