BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3050034 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03635
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    December 24, 2012
    Report Date
    June 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS RECEIVED VIA REMOTE MONITORING SYSTEM. THE PATIENT WAS BROUGHT IN FOR EVALUATION. SHOCK IMPEDANCE MEASUREMENTS HAD BEEN INCREASING SINCE (B)(6). THE PHYSICIAN CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REGARDING THE REVISION OF THIS LEAD DURING A POCKET REVISION FOR DEVICE MIGRATION. PACING IMPEDANCES HAD ALSO REPORTEDLY INCREASED DUE TO THE DEVICE MIGRATION. TS EXPLAINED THAT DEVICE MIGRATION MAY AFFECT SHOCK LEAD IMPEDANCES PARTICULARLY FOUND IN A FATTY TISSUE AREA. SINCE THE HIGHEST VALUE HAD BEEN 127 OHMS WITH NO EVENTS STORED WITH NOISE DISCUSSED JUST CONTINUED OBSERVATION AT THIS TIME. INFORMED PHYSICIAN THAT AN ADDITIONAL ALERT FOR OUT OF RANGE MEASUREMENTS WOULD LIKELY OCCUR. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153189 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening| R 0292| 4469| 0295| E142