BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3223590 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10623
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    January 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP PLANNED AT A LATER DATE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD THROUGH THE REMOTE MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ALL AVAILABLE INFORMATION INDICATES THAT NO INTERVENTION WAS PERFORMED AT THIS TIME AND THAT THE DEVICE AND LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION LATER RECEIVED INDICATED THAT THE PATIENT'S SHOCK IMPEDANCE MEASUREMENTS WERE 112 OHMS, WHICH WERE CONSIDERED STABLE CONSIDERING THAT THE SHOCK IMPEDANCE MEASUREMENTS AT IMPLANT WAS 100 OHMS. THUS, NO INTERVENTION WAS NECESSARY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE AND THE COMPETITOR'S RV LEAD CONTINUED TO EXHIBIT HIGH SHOCK IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION INDICATED THAT THE LATEST SHOCK IMPEDANCES HAVE REMAINED WITHIN RANGE AT THIS TIME; HOWEVER, INCREASED PACING THRESHOLD MEASUREMENTS WERE OBSERVED. THE HOSPITAL TECHNICIAN WILL CONSULT THE PHYSICIAN IF TECHNICAL ANALYSIS WAS NEEDED. THE PATIENT LATER PRESENTED FOR FOLLOW UP WITH NO OUT OF RANGE MEASUREMENTS OBSERVED. AN X-RAY WAS ALSO OBTAINED, WHICH SHOWED THE DEVICE IN A LOWER POSITION FROM WHERE IT WAS ORIGINALLY IMPLANTED. THE LEAD REMAINED IN PLACE, THOUGH. AN EXTRA FOLLOW UP WAS PLANNED AT A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ALL MEASUREMENTS AND TRENDS WERE WITHIN RANGE WHEN THE PATIENT PRESENTED FOR FOLLOW UP A MONTH AGO. FURTHER, PACING THRESHOLD MEASUREMENTS HAD ALSO NORMALIZED. HENCE, NORMAL FOLLOW UP WILL BE CONTINUED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322578 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1