BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3212989 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09186
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 1, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED ONE OUT-OF-RANGE (OOR) RV IMPEDANCE MEASUREMENT (GREATER THAN 2000 OHMS) AND ONE HIGH RV IMPEDANCE MEASUREMENT (1750 OHMS). IN REVIEW OF DAILY MEASUREMENTS (DM) DATING BACK TO (B)(6) 2012, ALL MEASUREMENTS WERE WITHIN NORMAL RANGE (400 OHMS). ADDITIONALLY, THE COMPETITOR RIGHT ATRIAL (RA) WAS EXHIBITING INCREASING RA IMPEDANCE MEASUREMENTS SINCE (B)(6) 2012. THE LOCAL REPRESENTATIVE SUSPECTS THAT THE ABNORMAL RV PACING IMPEDANCES WERE THE RESULT OF EMI INTERFERENCE DURING LEAD IMPEDANCE TESTING. THERE HAS BEEN NO INTRACARDIAC NOISE ON EITHER THE RV AND RA INTRACARDIAC CHANNELS. ALL OTHER LEAD DIAGNOSTIC MEASUREMENTS HAVE BEEN NORMAL. THE LOCAL REPRESENTATIVE HAVE BEEN UNABLE TO REPRODUCE THESE CLINICAL OBSERVATIONS. THE PATIENT IS NOT SYMPTOMATIC AND HAS NOT RECEIVED DEFIBRILLATION THERAPY. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE. ACCORDING TO THE LOCAL REPRESENTATIVE, THE PHYSICIAN DOES NOT SUSPECT ANY ISSUES AT THIS TIME BUT WILL CONTINUE TO MONITOR THE PERFORMANCE OF THE LEADS. THE LOCAL REPRESENTATIVE CONFIRMED THAT ALL OTHER LEAD DIAGNOSTIC MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO INTERVENTION (REPROGRAMMING OR INVASIVE) IS PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TS IN (B)(6) 2014. THE PATIENT WAS SEEN IN-CLINIC FOR A DEVICE CHECK. THE LOCAL REPRESENTATIVE COMMENTED THAT THE PATIENT'S COMPETITOR RIGHT ATRIAL (RA) LEAD HAD EXHIBITED A OUT-OF-RANGE RA IMPEDANCE OF GREATER THAN 2000 OHMS FROM (B)(6) 2013 TO (B)(6) 2014. THE CURRENT MEASURED RA IMPEDANCE VALUE IS 400 OHMS. NO INTERVENTION (REPROGRAMMING OR INVASIVE) INTERVENTION WAS PLANNED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE LOCAL REPRESENTATIVE PERFORMED PATIENT ISOMETRICS AND POCKET MANIPULATIONS. NO ELECTROGRAM NOISE WAS IDENTIFIED. THE PHYSICIAN PLANS TO CONTINUE MONITORING THE PERFORMANCE OF THIS DEVICE AND RA LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313908 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR E110| 0157| MISMATCH| A155