BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2081896 · Received May 9, 2011

    Report

    Report Number
    2124215-2011-08102
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 6, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE 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. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. 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 THE TRANSVENOUS RIGHT VENTRICULAR LEAD DID EXHIBIT OUT-OF-RANGE PACE IMPEDANCE IN ASSOCIATION WITH THIS PULSE GENERATOR. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED CLOSE FOLLOW-UP. THE FOLLOWING PHYSICIAN WAS ALREADY FOLLOWING THE PATIENT ON A MONTHLY BASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RV LEAD CONTINUED TO EXHIBIT INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE PATIENT WITH THIS DEVICE SYSTEM HAD NO UNDERLYING RHYTHM AND REPORTED FEELING UNCOMFORTABLE. A REVISION PROCEDURE WAS TO BE PERFORMED.

    Description of Event or Problem · 1

    APPROXIMATELY THREE YEARS LATER THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD). THE ASSOCIATED RV LEAD REMAINS IN SERVICE WITH THE NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 4087| 4035| 1298| 1290