BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1945580 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19988
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    June 8, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS BROUGHT IN FOR DEFIBRILLATION THRESHOLD (DFT) TESTING. VENTRICULAR FIBRILLATION (VF) WAS INDUCED AND THE FIRST SHOCK CONVERTED THE RHYTHM AT 27 JOULES. THE PHYSICIAN SUSPECTED THAT THE ORIGINAL RHYTHM WAS AN ATRIAL FLUTTER OR SUPRAVENT VENTRICULAR TACHYCARDIA (SVT) WITH ABERRANT CONDUCTION. DEVICE REPROGRAMMING OR AN ABLATION PROCEDURE PLANNED TO BE CONSIDERED IF THE PATIENT EXPERIENCED THIS RHYTHM AGAIN. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE DFT PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT RECOMMENDED HAVING AN ELECTROPHYSIOLOGIST REVIEW THE ELECTROGRAM DATA BEFORE MAKING AND POTENTIAL PROGRAMMING CHANGES. THE PATIENT HAS A SCHEDULED APPOINTMENT TO SEE AN ELECTROPHYSIOLOGIST, AND A BOSTON SCIENTIFIC FIELD REPRESENTATIVE WILL BE PRESENT DURING THE FOLLOW-UP TO MAKE ANY PROGRAMMING CHANGES, IF NEEDED. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    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. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    APPROXIMATELY SIX YEARS LATER THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT'S DEVICE DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND MULTIPLE SHOCKS, WHICH MAY HAVE TEMPORARILY EXHAUSTED TACHYCARDIA THERAPY. THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT REVIEWED EPISODE ELECTROGRAMS, BUT WAS UNABLE TO CONCLUDE WHETHER THE SHOCKS WERE APPROPRIATE OR NOT. THE PATIENT'S RHYTHM SPONTANEOUSLY TERMINATED BEFORE MEDICAL HELP ARRIVED. THE PATIENT WAS REPORTEDLY SYMPTOMATIC ONLY AFTER THE DEVICE BEGAN DELIVERING THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 0185| E110| 4136