BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2913646 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00079
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BROUGHT INTO THE OFFICE AND THE SHOCK IMPEDANCE WAS BACK TO ITS NORMAL RANGE IN THE 40 OHM RANGE. ALL OTHER MEASUREMENTS WERE WITHIN NORMAL LIMITS, THUS THE ISOLATED OUT OF RANGE VALUE WAS THOUGHT TO BE EMI AND NO FURTHER EVALUATION WAS PERFORMED. THE PHYSICIAN WILL CONTINUE TO FOLLOW THE PATIENT VIA THE REMOTE HOME MONITORING SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. UPON REVIEW OF THE DAILY MEASUREMENTS IT WAS NOTED THAT MOST IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE PATIENT PERFORMED AN INTERROGATION THROUGH THE REMOTE HOME MONITORING SYSTEM AND A READING OF ZERO OHMS WAS OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED POSSIBLE ELECTROMAGNETIC INTERFERENCE (EMI) AND TO INQUIRE WHAT THE PATIENT WAS DOING AT THE TIME THE READING CAME THROUGH ALONG WITH BRINGING THE PATIENT IN FOR EVALUATION. AN EMAIL WAS SENT TO THE FIELD REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21420 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4473| E110| 0185