BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3210367 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08829
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    July 23, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    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

    THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. 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 VIA THE PATIENT'S HOME REMOTE MONITORING SYSTEM THAT THIS RIGHT VENTRICULAR (RV) LEAD AND DEVICE DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE HAD NOT BEEN CONTACTED BY THE PATIENT'S CLINIC REGARDING ANY FOLLOW UP. THERE WERE NO ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER ALERT WAS RECEIVED FOR OUT-OF-RANGE SHOCK IMPEDANCE ON THE RV LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND FOUND THAT THE SHOCK IMPEDANCE HAD BEEN STABLE AT ABOUT 100-110 OHMS OVER THE PAST YEAR. TS RECOMMENDED CONTINUED MONITORING AND POTENTIALLY BRINGING THE PATIENT IN FOR COMMANDED SHOCK TESTING. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309729 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR E102| 0180