BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3905434 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10314
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 11, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, THE DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD NEW INFORMATION BE RECEIVED, THE EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENTLY, THE DEVICE WAS REPOSITIONED FROM A SUB-PECTORAL POSITION TO AN AUXILIARY LOCATION, AS A MEANS TO IMPROVE SENSOR RESPONSE DURING PHYSICAL ACTIVITY. THE MV SENSOR HAS BEEN RECALIBRATED POST INTERVENTION. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AND TO DATE THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE MINUTE VENTILATION (MV), SENSOR RESPONSE PROGRAMMING OF THIS DEVICE, CONTINUES TO BE UNSATISFACTORY. THE PATIENT REPORTED DIFFICULTY ACHIEVING ADEQUATE HEART RATES, ESPECIALLY DURING MODERATE TO STRENUOUS EXERCISE. THE PATIENT CONTINUES TO WORK DIRECTLY WITH BOSTON SCIENTIFIC ENGINEERS AND PHYSICIANS, TO OPTIMIZE SYSTEM PROGRAMMING AND PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383552 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J176

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention J176| 4470| 4471| J177