BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3971349 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14789
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 26, 2014
    Report Date
    November 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECORDS INDICATE THIS DEVICE AND LEAD REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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 VIA REMOTE MONITORING SYSTEM THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALONG WITH RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE MEASUREMENT OF GREATER THAN 2,000 OHMS. HIGH PACING THRESHOLD MEASUREMENTS WERE ALSO NOTED. THE PATIENT RARELY PACES SO THE HIGH THRESHOLD WAS NOT CONCERNING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSES AND RECOMMENDED PERFORMING A SAVE TO DISK AT THE NEXT FOLLOW - UP. THE CAUSE OF THE OUT-OF-RANGE IMPEDANCE MEASUREMENTS WAS NOT IDENTIFIED. THE PATIENT WILL BE SEEN IN CLINIC AT A LATER DATE AND A SAVE TO DISK IS PLANNED TO BE OBTAINED AT THAT TIME. THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS NOT PRESENTING TO CLINIC FOR FOLLOW-UP, HOWEVER WAS BEING MONITORED VIA REMOTE FOLLOW-UP. DEVICE DATA WAS REVIEWED AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS CONTINUE TO BE OBSERVED. CAPTURE WAS NOTED AND SHOCK IMPEDANCE MEASUREMENTS WERE ACCEPTABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446674 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR E140| 0285