BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1870053 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17488
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    June 11, 2010
    Report Date
    September 21, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING SHOCK IMPEDANCES. EVENTUALLY, SHOCK IMPEDANCES OF >125 OHMS WERE DISPLAYED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS WITH THE LOCAL FIELD REPRESENTATIVE (FR). SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT WAS BROUGHT IN TO THE OFFICE FOR FOLLOW UP. THE FOLLOW UP DID NOT REVEAL ANY ISSUES. THE PATIENT WILL CONTINUE TO BE MONITORED VIA LATITUDE AND AT NORMAL SCHEDULED CHECKS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATED THAT A NON-INVASIVE PROGRAMMED STIMULATION (B)(4) STUDY WAS PERFORMED. COMMANDED SHOCKS OF 1.1 JOULES AND 41 JOULES WERE PERFORMED WITH THE RESULTING IMPEDANCES OF 80 OHMS AND 83 OHMS, RESPECTIVELY. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention