BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2910621 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15630
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    December 3, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDUCTION TESTING WAS PERFORMED WHERE NO ISSUES WERE SEEN. SUBSEQUENTLY THE PHYSICIAN HAS OPTED TO CONTINUE TO MONITOR THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN SHOCKING IMPEDANCE MEASUREMENT THAT HAS NOW REACHED TO GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED PERFORMING HIGH ENERGY SHOCKS TO TEST THE INTEGRITY OF THE SYSTEM. THE FIELD REPRESENTATIVE WAS CONTACTED AND STATED THAT THE CLINIC HAS OPTED TO MONITOR THE PATIENT AND NO INTERVENTION WILL BE TAKEN AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17038 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R E102| 0180