BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3905416 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09404
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 21, 2014
    Report Date
    September 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS. IN ADDITION, THE IMPEDANCE MEASUREMENTS HAVE DECREASED SLIGHTLY. AMPLITUDE MEASUREMENTS HAVE DECREASED. PACING INHIBITION WAS OBSERVED. LEAD DISLODGEMENT WAS SUSPECTED. THE OUTPUT SETTINGS WERE REPROGRAMMED AND A REVISION PROCEDURE IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED, HOWEVER THE PATIENT WAS HOSPITALIZED. A REVISION PROCEDURE WAS PERFORMED. LEAD DISLODGMENT WAS NOT OBSERVED ON THE X-RAY OR BY VISUAL INSPECTION. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL, HOWEVER THE LEAD COULD NOT BE AFFIXED PROPERLY. A DECISION WAS MADE TO REPLACE THE LEAD. IT WAS THOUGHT THE LEAD POSITION MAY HAVE CAUSED THE ISSUE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383547 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4471| J175