BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELIGEN

    MDR report key: 2635133 · Received June 29, 2012

    Report

    Report Number
    2124215-2012-09065
    Event Type
    Death
    Date Received
    June 29, 2012
    Date of Event
    May 21, 2012
    Report Date
    October 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    --

    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.

    Additional Manufacturer Narrative · 1

    THE PATIENT CONTINUED TO BE MONITORED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED AN EPISODE OF SYNCOPE. THE PATIENT WAS ABLE TO CALL 911 JUST BEFORE THEY LOST CONSCIOUSNESS. EMERGENCY MEDICAL SERVICES ARRIVED AND NOTED THE PATIENT WAS IN TORSADES DE POINTES FOR WHICH THEY DELIVERED MULTIPLE EXTERNAL SHOCKS DURING ATTEMPTS TO STABILIZE THE PATIENT. THE PATIENT HAD NON-CAPTURE POST SHOCKS, HOWEVER WHEN THE FIELD REPRESENTATIVE EVALUATED THE PATIENT IN THE EMERGENCY ROOM, THE PATIENT WAS IN SINUS TACHYCARDIA. THE FIELD REPRESENTATIVE NOTED SHE WAS UNABLE TO CAPTURE THE RA AND RV DURING THRESHOLD MEASUREMENT TESTING. THE DEVICE WAS REPROGRAMMED TO AAI MODE AND A VT THERAPY ZONE WAS PROGRAMMED. LATER THAT DAY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED TO REVIEW THE ARRHYTHMIA AND POSSIBLE UNDERSENSING WAS DISCUSSED. TS DISCUSSED THAT THE RV ELECTROGRAM (EGM) CHANNEL, ALTHOUGH NOT CLEAN IN APPEARANCE, DID NOT APPEAR TO BE MISSING ANY SIGNALS WHEN IT WAS COMPARED TO THE SHOCK EGM MORPHOLOGY. SOME EXTRA SIGNALS NOTED ON THE RV CHANNEL WERE LIKELY DUE TO WHERE THE SHOCK LEAD WAS POSITIONED IN THE PATIENT'S HEART. IT WAS NOTED THAT THE PATIENT'S ARRHYTHMIA ORIGINATED IN A RATE BELOW THE DEVICE PROGRAMMED RATE CUTOFF (RCO) AND ACCELERATED TO A MONITOR ONLY (MO) ZONE OF 160-200 BPM. RV LOSS OF CAPTURE (LOC) WAS NOTED ONCE THE PATIENT HAD ARRIVED TO THE HOSPITAL SETTING. UPON REVIEW OF THE STORED EGMS, TS COULD NOT CONFIRM LOSS OF CAPTURE. SOME OF THE RV PACED EVENTS MIGHT HAVE BEEN PACING INTO INTRINSIC DEPOLARIZATION WHICH LOOKED LIKE FUSION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT A REPRESENTATIVE FOR THIS PATIENT HAS FILED A LAWSUIT. THE LEGAL CLAIM INCLUDED INFORMATION OBTAINED FROM FOUR DIFFERENT MEDICAL FACILITIES, WHERE TWO PHYSICIANS WERE SPECIFICALLY NAMED. THE MEDICAL RECORDS WERE REVIEWED BY A MEDICAL MALPRACTICE ATTORNEY. HIS DESCRIPTION PROVIDED SOME NEW INFORMATION AS WELL AS SOME CLARIFICATION TO THE ORIGINAL INFORMATION SUBMITTED. IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 WITH CHEST DISCOMFORT AND QUESTIONABLE PROBLEMS WITH THE RIGHT VENTRICULAR (RV) LEAD DUE TO INCREASED THRESHOLDS. NO INTERVENTION WAS REQUIRED AFTER A CHEST X-RAY AND ECHOCARDIOGRAM WERE UNREVEALING. THEN, FOUR DAYS LATER THE PATIENT SUFFERED THE CARDIAC ARREST AND WAS FOUND TO BE IN VENTRICULAR TACHYCARDIA AT A RATE OF APPROXIMATELY 170-180 BPM. THE PATIENT WAS RESUSCITATED, BUT NEVER REGAINED CONSCIOUSNESS AND WAS DECLARED BRAIN DEAD AND THEN SUBSEQUENTLY DIED. THE MEDICAL RECORDS VALIDATED THE ICD DID NOT SHOCK THE PATIENT BECAUSE THE VT RATE WAS BELOW THE PROGRAMMED RATE CUT OFF OF 200 BPM. AN EKG AND CARDIAC MRI WERE CONSISTENT WITH THE AUTOPSY DEMONSTRATING AN RIGHT VENTRICULAR CARDIOMYOPATHY CHARACTERIZED AS ARRHYTHMOGENIC RIGHT VENTRICULAR DYSPLASIA WITH FATTY INFILTRATION OF THE RIGHT VENTRICLE. THE ATTORNEY CONCLUDED THAT BASED ON HIS EDUCATION, TRAINING AND EXPERIENCE, HIS OPINION IS THAT BOTH PATIENT'S PHYSICIANS WERE NEGLIGENT AND FAILED TO MEET THE AFOREMENTIONED STANDARDS OF CARE IN THEIR MANAGEMENT OF THE PATIENT. THE ATTORNEY BELIEVED THE PHYSICIANS BREACHED THE STANDARDS OF CARE, INCLUDING NEGLIGENT ACTS AND OMISSIONS IN THEIR EVALUATION AND TREATMENT OF THE PATIENT; AND AS A RESULT, CAUSED HER SUBSEQUENT CARDIAC ARREST AND BRAIN DEATH. THE ATTORNEY BELIEVED THE CARDIAC ARREST LEADING TO THE PATIENT'S DEATH WAS PREVENTABLE IF THE PHYSICIANS HAD COMPLIED WITH THE STANDARDS OF CARE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S STATUS HAD BEEN CHANGED TO DO NOT RESUSCITATE (DNR) AND THE DEVICE TACHY THERAPY WAS PROGRAMMED OFF. THE PATIENT EXPIRED (B)(6) DAYS AFTER THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| H| L 4469| 0180| E110