BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3951214 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14280
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND COMPETITOR RIGHT VENTRICULAR (RV) LEAD DISPLAYED LOW OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT ELECTROMAGNETIC INTERFERENCE (EMI) WAS ASSUMED TO BE THE CULPRIT HOWEVER WAS NOT CONCLUSIVELY DETERMINED. NO FURTHER TESTING AND OFFICE VISITS ARE SCHEDULED. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428378 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4136| 4092| N161| N119| MISMATCH| 7120| 1184