BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3760898 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08713
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PHYSICIAN

    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 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT WAS OVERSENSED AND LED TO PACING INHIBITION. IT WAS UNKNOWN IF OR HOW LONG THE PATIENT EXPERIENCED ASYSTOLE. THE LEAD WAS SURGICALLY ABANDONED AND CAPPED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240211 INGENIO IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND V172

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 4470| S606| 4517| V172| 4136| 4137