BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911554 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16234
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    October 11, 2017
    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

    AT THIS TIME, NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED A LOW, OUT-OF-RANGE (OOR), SHOCK IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. ON THE DATE THE OOR VALUE WAS DETECTED A HEALTH CARE PROFESSIONAL (HCP) CALLED FROM A HOSPITAL AND INQUIRED ABOUT MAGNET USE FOR THIS PATIENT'S DEVICE DURING SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE PATIENT WAS EVALUATED BY HIS FOLLOWING CLINIC, AND THE DEVICE CHECK WAS NORMAL WITH NO ISSUES IDENTIFIED. THE FIELD REPRESENTATIVE HAD NO FURTHER INFORMATION RELATED TO THE PROCEDURE THAT MAY HAVE BEEN DONE ON THE DAY THE LOW SHOCK IMPEDANCE WAS DETECTED. AT THIS TIME, NORMAL FOLLOW-UP WAS PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE YEARS LATER THIS DEVICE WAS EXPLANTED FOR AN UNRELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17779 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR E102| 0185| T175