BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3971338 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14826
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 20, 2014
    Report Date
    September 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EMITTING BEEPING TONES AS THERE WERE HIGH OUT OF RANGE (OOR) LEFT VENTRICULAR PACING IMPEDANCE OF GREATER THAN 2,000 OHMS. THE PATIENT WAS SEEN AGAIN DUE TO HIGH OUT OF RANGE LV PACING IMPEDANCE MEASUREMENTS. HIGH PACING THRESHOLD WAS ALSO NOTED AT THAT TIME. TROUBLESHOOTING WAS PERFORMED AND THAT THE CAUSE OF THE OUT OF RANGE MEASUREMENTS WAS NOT DETERMINED. DURING TROUBLESHOOTING LOSS OF CAPTURE (LOC) AND INCREASED THRESHOLDS WERE SEEN IN A DIFFERENT VECTOR. AN X-RAY WAS PERFORMED AND A DISLODGEMENT WAS SUSPECTED BUT NOT CONFIRMED. ADDITIONAL INFORMATION RECEIVED THAT INCREASED THRESHOLD DID NOT RESULT IN LOC. THE PATIENT IS NOT PACER DEPENDENT AND THE PHYSICIAN PLANNED FOR A FOLLOW-UP CHECK. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT WAS SEEN FOR A REVISION PROCEDURE. WHEN THE DEVICE WAS EXPLANTED, THERE WAS PRESENCE OF BLOOD IN THE LV PORT OF THE HEADER. WHEN THE PHYSICIAN INSERTED THE WRENCH INTO THE SEAL PLUG, FLUID CAME OUT. THE LV LEAD WAS TESTED THROUGH THE PACING SYSTEMS ANALYZER AND WAS NOTED TO HAVE NORMAL LEAD PERFORMANCE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446377 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R MISMATCH| 4136| N140| 0296