BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3904511 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10005
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS AT THE PATIENT'S ONE MONTH POST-IMPLANT FOLLOW UP. ALL OTHER VALUES WERE WITHIN NORMAL LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED DATA STORED TO THE DEVICE AND INDICATED THAT IMPEDANCES APPEAR TO HAVE INCREASED GRADUALLY AND STABILIZED AROUND 2,100 OHMS. IT WAS RECOMMENDED TO CLOSELY MONITOR THE PATIENT GOING FORWARD TO ASSESS WHETHER THE LEAD STABILIZES. THE LEAD WILL BE REASSESSED IN 2 MONTHS. THE PATIENT WAS REPORTED TO NOT BE PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384596 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND F142

    Patients

    Seq Age Sex Outcome Treatment
    1 F142| 4096| 0282