BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3213049 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10449
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    April 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. DEVICE DATA FROM THE (B)(4) 2014 DEVICE CHECK WAS SUBMITTED TO ENGINEERING FOR REVIEW. IT WAS NOTED THAT HIGH RATES OF ATRIAL SENSING WAS LIKELY THE CAUSE OF THE INCREASED POWER CONSUMPTION AND PREMATURE BATTERY DEPLETION. THE ATRIAL SENSING WAS PROGRAMMED OFF AT THIS DEVICE CHECK. ENGINEERING DISCUSSED THAT THE DEVICE WOULD NEED ABOUT 30 DAYS OF MEASUREMENTS AT THE NEW SETTINGS TO FULLY REFLECT THE NEW, MORE EXPECTED POWER CONSUMPTION. THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. IT WAS REPORTED THAT A SAVE TO DISK WOULD BE CREATED AT THE PATIENT'S NEXT SCHEDULED FOLLOW-UP. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER HAD BEEN IMPLANTED FOR THREE MONTHS. AT THE DEVICE CHECK, THE REMAINING LONGEVITY WAS 5.5 YEARS REMAINING. PREMATURE BATTERY DEPLETION WAS SUSPECTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT REVIEWED SOME DEVICE DATA, BUT WAS NOT ABLE TO DETERMINE A CAUSE FOR THE DECREASE IN REMAINING LONGEVITY. A SAVE TO DISK WOULD BE REQUIRED FOR TECHNICAL SERVICES TO PROVIDE A MORE DETAILED ANALYSIS ON THE DEVICE LONGEVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311907 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J173

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR