BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3971353 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-10769
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 2, 2014
    Report Date
    January 29, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH PACEMAKER HAD A LEAD SAFETY SWITCH TRIPPED ON A COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD AND HAD NON-SUSTAINED EVENTS DUE TO OVERSENSING. ADDITIONAL INFORMATION INDICATES THAT HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE WAS EXHIBITED. THE DEVICE WAS CHANGE TO UNIPOLAR, HOWEVER WHEN CHANGED BACK TO BIPOLAR THE IMPEDANCE MEASUREMENTS WERE NORMAL. THE PHYSICIAN QUESTIONED AN ELECTROMAGNETIC INTERFERENCE (EMI), HOWEVER THIS WAS NOT CONCLUSIVELY DETERMINED. FURTHER, PATIENT WILL BE SEEN FOR DEVICE INTERROGATION IN A MONTH. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446724 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R K173| 1688TC