BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIENT

    MDR report key: 2162568 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07068
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    August 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS ELECTIVELY EXPLANTED. THE RV LEAD WAS EXPLANTED DUE TO OBSERVATIONS OF INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS, OVERSENSING WITH NO REPORT OF PACING INHIBITION, INCREASED PACING THRESHOLD MEASUREMENTS AND NOISE REPRODUCED DURING ISOMETRIC EXERCISES. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING HIGH PACING IMPEDANCE MEASUREMENTS NEAR 3,000 OHMS. THE PHYSICIAN REQUESTED ADVICE FROM BOSTON SCIENTIFIC TECHNICAL SERVICES WHO INDICATED IF ALL OTHER MEASUREMENTS WERE STABLE AND THE PHYSICIAN DID NOT WANT TO OPEN UP THE POCKET, THEY COULD CONTINUE TO MONITOR. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR E030| 0185| T175