BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3904303 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09594
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 11, 2014
    Report Date
    June 27, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT ELECTED NOT TO HAVE THE DEVICE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE FIELD REPRESENTATIVE THAT DEVICE REPLACEMENT WAS RECOMMENDED. DISK ANALYSIS WAS OFFERED, BUT WAS DECLINED. AT THIS TIME, INFORMATION SUGGESTS THAT THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS OBTAINED THAT THE PATIENT WAS SEEN AND THE CODE 1003 SCREEN WAS OBSERVED. THE FIELD REPRESENTATIVE WAS UNABLE TO GET FURTHER AS A RED SCREEN WITH END SESSION WAS THEN DISPLAYED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT LIKELY THERE WAS ANOTHER CODE PRESENT, BUT UNTIL THE DEVICE IS RETURNED AND ANALYZED IT IS UNKNOWN WHAT THAT CODE IS. AT THIS TIME, THE DEVICE SYSTEM REMAINS IMPLANTED AS THE FAMILY HAS CHOSEN TO NOT REPLACE THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384166 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4469| E110| T125| 0157