BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3212999 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09945
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    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

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE AND NON-BOSTON SCIENTIFIC LEADS PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING A SYNCOPAL EPISODE WITH AN UNDERLYING ESCAPE RHYTHM. INTERROGATION REVEALED LOSS OF CAPTURE HAD OCCURRED. IN ADDITION, THRESHOLD MEASUREMENTS HAVE FLUCTUATED AND STEADILY INCREASED THE RIGHT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS HAVE ALSO INCREASED SINCE IMPLANT TEN YEARS AGO. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND REVIEWED THE INFORMATION. IT WAS NOTED A LARGE NUMBER OF RIGHT VENTRICULAR AUTO THRESHOLD TESTS HAD OCCURRED; POSSIBLY DUE TO THE INSTABILITY OF THE THRESHOLDS CAUSING THE DEVICE TO SUSPEND, THEN AMBULATORY TEST AND BACK TO BEAT TO BEAT DELIVERY. IN ADDITION, IT WAS THOUGHT THIS MAY BE DUE TO AN UNDERLYING LEAD INTEGRITY ISSUE THAT MAY HAVE BEEN COMPROMISED DURING THE IMPLANT OF THIS DEVICE OR THIS MAY BE PATIENT OR MEDICATION COMPLIANCE RELATED. FURTHER SYSTEM TESTING WILL BE PERFORMED ONCE THE PATIENT HAS BEEN STABILIZED. AT THIS TIME; NO DECISION HAS BEEN MADE REGARDING LEAD REVISION. IT WAS THOUGHT THIS ISSUE WAS LEAD RELATED, HOWEVER ALSO DUE TO THE LIMITATIONS OF THE ALGORITHM TO PROVIDE AN ADEQUATE OUTPUT DURING THE "SUSPENSION" PERIOD OF AUTO CAPTURE. AT THIS TIME, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO FURTHER ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313352 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K184

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L