BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3211488 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08005
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DECLARED DUE TO A OUT OF RANGE HIGH SHOCK IMPEDANCE GREATER THAN 129 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED TO REVIEW THE ALERT. THE AGENT CONFIRMED THAT A HIGH OUT OF RANGE SHOCK IMPEDANCE GREATER THAN 129 OHMS OCCURRED AND THEN REVERTED BACK TO 102 OHMS. IN ADDITION NO NOISE WAS FOUND ON THE ELECTROGRAM (EGM). IN CONCLUSION, THE AGENT CONFIRMED THERE WAS NO EVIDENCE OF A MECHANICAL ISSUE WITH THE LEAD AS ALL STORED EPISODES ARE FREE OF NOISE AND ADDITIONAL LEAD TESTING WAS RECOMMENDED TO EVALUATE THE LEAD INTEGRITY. THE PATIENT PHYSICIAN IS AWARE OF THE SITUATION AND THE PATIENT WILL BE MONITORED CLOSELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309541 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F160

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening