BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3041284 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03017
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE INTERROGATION, HIGH SHOCK IMPEDANCES GREATER THAN 200 OHMS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. A CONNECTION ISSUE WAS SUSPECTED FROM THE RECENT DEVICE CHANGE OUT. THE PATIENT HAD BEEN SENT HOME WITH NO INTERVENTION OR LEAD TESTING PERFORMED AT THAT TIME. ONE MONTH FOLLOWING, THE PATIENT WAS SEEN AGAIN IN CLINIC AND OUT OF RANGE SHOCK IMPEDANCES CONTINUED TO BE OBSERVED WITH TRIAD CONFIGURATION PROGRAMMING. POCKET MANIPULATION WAS PERFORMED WITH NO EVIDENCE OF NOISE. THE PHYSICIAN CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DURING PROGRAMMING CONFIGURATION CHANGES TO DISTAL LEAD TIP TO CAN WHICH THEN IMPEDANCES WERE OBSERVED AT 72 OHMS. THE PATIENT WAS AGAIN SENT HOME WITH THAT PROGRAMMING. DURING THE CONVERSATION IT WAS DISCUSSED TO PERFORM DEFIBRILLATION THRESHOLD (DFT) TESTING TO RULE OUT POSSIBLE LEAD PERFORMANCE ISSUES. A REQUEST FOR LEAD STATUS HAS BEEN SENT. THERE WERE NO ADVERSE PATIENT EFFECTS OR SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143909 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR T127| 0184| 4086| E143