BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3790191 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-06732
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    August 1, 2013
    Report Date
    July 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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 PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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. 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. NO DEVICE CHARACTERISTICS WERE IDENTIFIED DURING ANALYSIS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT UNDERWENT AN ATTEMPTED EXPLANT PROCEDURE THAT WAS UNSUCCESSFUL AS THE PHYSICIAN WAS UNABLE TO IMPLANT A NEW LEAD DUE TO A THROMBOSIS IN THE PATIENTS SUPERIOR VENA CAVA. UPON REATTEMPTING EXPLANT, A NEW LEAD WAS PLACED AND THE CHRONIC RV LEAD SURGICALLY ABANDONED. THE CHRONIC ICD WAS ALSO EXPLANTED AND REPLACED. THE SUSPECTED LEAD FRACTURE COULD NOT BE CONFIRMED VIA FLUOROSCOPY OR VISUALLY DURING THE REVISION PROCEDURE. IT WAS FURTHER NOTED THAT AN EPISODE WAS STORED TO THE DEVICE EXHIBITING NOISE AND OVERSENSING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD AND DEVICE ARE NO LONGER IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT MULTIPLE HIGH OUT-OF-RANGE SHOCKING IMPEDANCE MEASUREMENTS WERE OBSERVED ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD THROUGH THE REMOTE MONITORING SYSTEM. IT WAS REPORTED THAT ALL OTHER MEASUREMENTS WERE WITHIN RANGE. A LEAD FRACTURE WAS SUSPECTED AND THE PHYSICIAN WAS PLANNING TO REPLACE THE LEAD ON AN UNSPECIFIED DATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ALSO REVIEWED THE SUBMITTED PATIENT DATA AND NOTED THAT THE SHOCK IMPEDANCE HAVE BEEN GRADUALLY INCREASING SINCE ABOUT SIX MONTHS AGO. TS DISCUSSED THE POTENTIAL CAUSES AND SUGGESTED MEASURES TO EVALUATE THE SYSTEM. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266726 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR 0161| F110