BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENERGEN

    MDR report key: 2873741 · Received December 14, 2012

    Report

    Report Number
    2124215-2012-16655
    Event Type
    Death
    Date Received
    December 14, 2012
    Date of Event
    November 24, 2012
    Report Date
    December 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE ICD IDENTIFIED AN ARC MARK ON THE DEVICE CASE. THE DEVICE WAS CONFIRMED TO BE IN SAFETY MODE. REVIEW OF STORED MEMORY FOUND A SHORTED LEAD FAULT WAS RECORDED ON (B)(4) 2012 AFTER A FIFTH SHOCK WAS DELIVERED. AN X-RAY OF THE DEVICE REVEALED THAT THE INTERNAL HIGH VOLTAGE FUSE WAS DAMAGED (I.E., NO LONGER INTACT). THE DAMAGE TO THE FUSE MOST LIKELY OCCURRED DURING DELIVERY OF THE FIFTH SHOCK THAT RESULTED IN THE SHORTED SHOCK LEAD FAULT. THE DEVICE THEN RECORDED AN ADDITIONAL FAULT INDICATING LEAKAGE OF ENERGY ON THE LEADS, INDICATIVE OF EXTERNAL SHOCKS BEING DELIVERED. AS A RESULT, THE DEVICE EXPERIENCED THREE SYSTEM RESETS WHICH CAUSED THE DEVICE TO GO INTO SAFETY MODE. LABORATORY ANALYSIS CONCLUDED THAT THIS DEVICE WAS INITIALLY DAMAGED AS A RESULT OF A SHORTED LEAD CONDITION THAT OCCURRED DURING SHOCK DELIVERY. THE DEVICE ENTERED SAFETY MODE AFTER EXTERNAL DEFIBRILLATION WAS PROVIDED TO THE PATIENT. HOWEVER, THE DAMAGE TO THE HIGH VOLTAGE FUSE WOULD HAVE PREVENTED ANY SUBSEQUENT CHARGING OF THE HIGH VOLTAGE CAPACITORS AND FURTHER DELIVERY OF SHOCK THERAPY.

    Additional Manufacturer Narrative · 1

    A MEMORY DOWNLOAD WAS OBTAINED AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION OF THE EPISODE PRIOR TO THE PATIENT'S DEATH. REVIEW OF THE EPISODE (V-28) THAT OCCURRED ON (B)(6) 2012 REVEALED THE DEVICE DETECTED A FAST, IRREGULAR RHYTHM THAT WAS EVENTUALLY CLASSIFIED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED AND THE RHYTHM ACCELERATED INTO THE VENTRICULAR FIBRILLATION (VF) ZONE. AS A RESULT, A 26 JOULE SHOCK WAS DELIVERED. THE ARRHYTHMIA WAS NOT CONVERTED. IT WAS REDETECTED IN THE VT ZONE. ANOTHER 26 JOULE SHOCK WAS DELIVERED, FOLLOWED BY A 41 JOULE SHOCK WHEN THE ARRHYTHMIA CONTINUED. THIS 41 JOULE SHOCK WAS DELIVERED INTO A SHORTED LEAD CONDITION. ALL AVAILABLE INFORMATION INDICATES THAT THE ICD DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. A SHOCK (APPROPRIATE PER DEVICE PROGRAMMING, BUT INAPPROPRIATE BY PATIENT'S NEEDS) WAS DELIVERED DUE TO PATIENT'S CONDITION OF ATRIAL ARRHYTHMIA, WHICH LED TO THE VF. THE NON-BSC LEAD WAS UNABLE TO DELIVER THE REQUIRED THERAPY AND THE PATIENT SUBSEQUENTLY EXPIRED. OUR INVESTIGATION REFUTES ANY DEVICE MALFUNCTION AS THE DELIVERED SHOCK WAS APPROPRIATE PER PROGRAMMING. 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 DURING AN UNRELATED HOSPITAL STAY, THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVELOPED AN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE ICD DELIVERED SHOCKS WHICH THEN INDUCED A VENTRICULAR FIBRILLATION (VF). THE ARRHYTHMIA WAS DETECTED AND SHOCK THERAPY WAS DELIVERED BUT IT DID NOT CONVERT THE PATIENT'S VF. EXTERNAL DEFIBRILLATION WAS ADMINISTERED BUT WAS ALSO UNSUCCESSFUL. A MAGNET WAS APPLIED TO THE DEVICE AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED; HOWEVER, THE INTERVENTION DID NOT RESULT IN CARDIAC OUTPUT AND THE PATIENT DIED. THE ICD WAS INTERROGATED AND IT WAS NOTED THAT IT WAS IN SAFETY MODE. THE DEVICE WAS DEACTIVATED AND EXPLANTED TWO DAYS LATER TO RETURN TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. ALTHOUGH THERE WERE NO DIRECT ALLEGATIONS AGAINST THE DEVICE, IT IS UNKNOWN IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE ICD WAS RETURNED FOR LABORATORY ANALYSIS. THE RIGHT VENTRICULAR (RV) LEAD ASSOCIATED WITH THIS ICD IS A COMPETITOR'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F141

    Patients

    Seq Age Sex Outcome Treatment
    1 Death