BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3212660 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09567
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 29, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    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

    (B)(4). AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED ANALYSIS WILL BE PERFORMED AND THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

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    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

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION NOTED THAT THE RV LEAD HAD NOT BEEN FULLY INSERTED BY EVIDENCE OF THE LEAD SEAL RING MARKS IN THE HEADER RV PORT. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT-OF-RANGE SHOCK LEAD IMPEDANCE VIA THE PATIENT¿S MONITORING SYSTEM. THIS IS AN ON-GOING ISSUE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO ACTION WILL BE TAKEN AT THIS TIME. THERE HAS BEEN NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH A REMOTE MONITORING SYSTEM THAT DETECTED AN OUT OF RANGE HIGH SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS NO INFORMATION IMMEDIATELY AVAILABLE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SHOCK IMPEDANCE MEASUREMENT FOR THE RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONTINUED TO BE HIGH AND OUT OF RANGE. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE ICD WAS EXPLANTED AND THE RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312353 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R T125| 4469| E110