BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2040907 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01035
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 31, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES TO DISCUSS THE POSSIBILITY THAT THE HIGH-VOLTAGE TERMINAL PINS MAY BE REVERSED IN THE DEVICE'S HEADER. THE CLINIC NURSE ASKED HOW THE SHOCK LEAD INTEGRITY TEST WAS PERFORMED. TECHNICAL SERVICES DISCUSSED HOW THIS TEST IS MEASURED IN THE PROGRAMMED SHOCK VECTOR AND THAT AN OUT-OF-RANGE IMPEDANCE WOULD NOT NECESSARILY BE MEASURED IF THE DF-1 TERMINAL PINS WERE REVERSED. TECHNICAL SERVICES EXPLAINED THAT THIS ISSUE MAY BE ASSOCIATED WITH ACCENTUATED P-WAVE ON THE SHOCK CHANNEL MATCHING UP WITH RA CHANNEL ACTIVITY AND THE POSSIBLY OF MORE ELECTROGRAM NOISE ON THE SHOCK CHANNEL FROM CHEST MOTION.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FROM THAT THIS DEVICE'S TACHYCARDIA MODE WAS PROGRAMMED OFF AND THE DEVICE REMAINS IMPLANTED. THE PATIENT'S CHRONIC MODEL#0125 WAS NOT EXTRACTED. THE PHYSICIAN PLANNED TO SCHEDULE THE PATIENT FOR A FUTURE EXTRACTION PROCEDURE. A BI-VENTRICULAR DEVICE AND LEAD SYSTEM WERE IMPLANTED ON THE OPPOSITE SIDE. A NUMBER OF LEADS WERE ATTEMPTED, BUT NOT IMPLANTED DUE TO TORTUOUS ANATOMY (PATIENT CONDITION).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXHIBITING OVERSENSING FOLLOWING RIGHT ATRIAL (RA) BEATS. THE PATIENT IS PACEMAKER DEPENDENT AND PACING INHIBITION WAS IDENTIFIED. TECHNICAL SERVICES SUGGESTED THAT ADJUSTING THE RV SENSITIVITY SHOULD NOT BE UNDERTAKEN WITHOUT DEFIBRILLATION THRESHOLD TESTING (DFT). SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THE LATITUDE PRESENTING ELECTROGRAMS SHOWS THAT THE RV DEFIBRILLATION LEAD IS SENSING ATRIAL ACTIVITY. PATIENT WAS REPORTING PRESYNCOPE (DIZZY SPELLS). TECHNICAL SERVICES REVIEWED THE LATITUDE ELECTROGRAMS AND THE ASSOCIATED PACING INHIBITION. TECHNICAL SERVICES DISCUSSED HOW INTRINSIC AMPLITUDES ARE MEASURED IN THE DEVICE. IT APPEARS THAT AN XRAY SHOWS THAT THE RV LEAD HAS NO SLACK AT THE DISTAL END WHICH MAY ALLOW THE COIL TO PICK-UP THE ATRIAL SIGNALS. THE RV SENSITIVITY WAS REPROGRAMMED TO 0.8 MV. THE PATIENT HAS BEEN SCHEDULED FOR REATTEMPT OF A BI-VENTRICULAR SYSTEM AND THE PHYSICIAN MAY REVISE THE RV DEFIBRILLATION LEAD AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| O 1860| 0125| E102| 1762