BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 8537569 · Received April 22, 2019

    Report

    Report Number
    2124215-2019-07210
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    March 11, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 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 · 0

    IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF THIS DEVICE, UPON LEAD INSERTION, THE PACING FREQUENCY WAS LOWER THAN THE MARKED FREQUENCY. FOR THIS REASON, THE DEVICE WAS REMOVED AND RETURNED FOR ANALYSIS. NO RESULTING ADVERSE PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF ANALYSIS, A FOLLOW-UP REPORT WILL BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF THIS DEVICE, UPON LEAD INSERTION, THE PACING FREQUENCY WAS LOWER THAN THE MARKED FREQUENCY. FOR THIS REASON, THE DEVICE WAS REMOVED AND RETURNED FOR ANALYSIS. NO RESULTING ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329722 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 296495

    Patients

    Seq Age Sex Outcome Treatment
    1