BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1952586 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23461
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    June 24, 2010
    Report Date
    December 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    1-782275554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS ICD WAS THOROUGHLY INSPECTED AND ANALYZED. PIN GAUGE TESTING CONFIRMED THAT ALL PORT DIAMETERS WERE WITHIN DESIGN SPECIFICATION RANGE; HOWEVER, THE DIAMETER OF THE RV SPRING CONTACT COMPONENT WAS FOUND TO BE OUT-OF-SPECIFICATION. THIS MAY HAVE RESULTED IN A SUBOPTIMAL CONNECTION WITH THE LEAD TERMINAL. IT IS LIKELY THAT THE CLINICAL ALLEGATIONS WERE A DIRECT RESULT OF THE OUT-OF-SPECIFICATION LEAF SPRING CONTACT COMPONENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES WHICH REVEALED NOISE, WHICH WAS OVERSENSED. THERE WERE NO PATIENT SYMPTOMS REPORTED AND THE NOISE DID NOT CAUSE INHIBITION OF PACING. IT WAS REPORTED THAT THE PATIENT'S ICD WAS ELECTIVELY EXPLANTED DURING A PROCEDURE IN WHICH THE PATIENT'S CHRONIC LEADS WERE REPLACED.

    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 10902 DA (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)