BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2910716 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16492
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    September 29, 2012
    Report Date
    January 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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. THIS LABORATORY FINDING MAY HAVE CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE, 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 SURGICAL INTERVENTION WAS PERFORMED, THIS DEVICE AND RV LEAD WERE EXPLANTED AND A NEW ICD SYSTEM WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM HAVE EXHIBITED NOISE WITH OVERSENSING AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY DELIVERY. NO SHOCKS HAVE BEEN DELIVERED DUE TO THE ISSUE. UPON EVALUATION NOISE WAS ABLE TO BE REPRODUCED WITH ISOMETRICS AND, AT TIMES, LOW OUT-OF-RANGE (OOR) PACING IMPEDANCES OF LESS THAN 200 OHMS WERE MEASURED. THE OVERALL PACING IMPEDANCE HAS TRENDED DOWNWARD FROM 800 OHMS AT IMPLANT APPROXIMATELY THREE YEARS AGO TO 300 OHMS MORE RECENTLY. LEAD FLUOROSCOPY WAS DONE AND NO VISIBLE ANOMALIES WERE IDENTIFIED. THE GENERATOR WAS IMPLANTED SUBPECTORALLY AND IS PART OF THE SUBPECTORAL IMPLANT ADVISORY THAT WAS COMMUNICATED IN (B)(6) 2009. AT THIS TIME, SURGICAL INTERVENTION IS BEING ANTICIPATED IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16413 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R 0180| E102