BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3905627 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11628
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A POST OPERATIVE FOLLOW UP PACING FAILURE WAS SEEN ON THIS RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT SENSING AND PACING IMPEDANCES APPEARED NORMAL, ALTHOUGH PACING THRESHOLDS INCREASED SINCE THE IMPLANT. A LEAD DISLODGMENT WAS SUSPECTED AND CONFIRMED UPON OPENING THE POCKET. A REPOSITIONING PROCEDURE WAS PERFORMED. DURING THE PROCEDURE A STYLET WAS INSERTED INTO THIS RIGHT VENTRICULAR LEAD AND IT WAS NOTED THAT THE LEAD EASILY DISCONNECTED FROM THE DEVICE. IT WAS NOTED THAT THE DEVICE SETSCREW WAS NOT SECURE. THIS RIGHT VENTRICULAR LEAD WAS REPOSITIONED AND FIXATED INTO THE DEVICE HEADER. THE PATIENT HAD TOUCHED THE DEVICE THUS THE DEVICE WAS ELECTED TO BE REPLACED TO PREVENT AN INFECTION. THE EXPLANTED DEVICE WILL NOT BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384489 INGENIO IMPLANTABLE PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND J177

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R J177| 4469| 4470