BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3210223 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09387
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 21, 2013
    Report Date
    August 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS WHICH WAS DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. THE PATIENT WAS SEEN IN CLINIC FOR FOLLOW UP WHERE THE SHOCK LEAD IMPEDANCE (SLI) WAS TESTED RESULTING IN A 116 OHM READING. IT WAS NOTED THAT THE LEAD WAS A SINGLE COIL AND THE SLI HAD BEEN TRENDING ON THE HIGH SIDE WITH A GRADUAL INCREASE SINCE IMPLANT. THE PATIENT WAS TO BE MONITORED. SUBSEQUENT INFORMATION INDICATED THAT ADDITIONAL MEASUREMENTS OF GREATER THAN 125 OHMS WERE RECORDED. THE PATIENT WAS SEEN AGAIN FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING WHICH RESULTED IN A 80 OHM MEASUREMENT. THE SYSTEM WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS SEEN FOR DEVICE TESTING. A COMMANDED SYNCHRONIZED 41 JOULE (J) SHOCK RETURNED A MEASUREMENT OF 93 OHMS. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS ALSO PERFORMED. DFT WAS UNSUCCESSFUL WITH A 11J SHOCK BUT WAS SUCCESSFUL WITH A 31J SHOCK. THE SHOCK IMPEDANCES WERE 95 OHMS AND 93 OHMS, RESPECTIVELY. THE SYSTEM WILL CONTINUE TO BE MONITORED AND REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310044 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R 0292| S603| 4543| 4469| 4456| N140