BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 4131709 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14844
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003/S106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVISION TOOK PLACE, THE LEAD AND THE DEVICE WERE EXPLANTED. THE LEAD AND DEVICE WILL NOT BE RETURNED. IT WAS NOTED THAT AYSTOLE FOR APPROXIMATELY TWO SECONDS WAS SEEN ON THE HOLTOR MONITOR ALTHOUGH THE EXACT VALUE WAS NOT AVAILALBE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP A SUSPICION OF PACING FAILURE WAS NOTED. NO ISSUE WAS FOUND WHEN INTERROGATING THE DEVICE, BUT VENTRICULAR PACING FAILURE WAS OBSERVED ON THE HOLTER MONITOR RECORDED ON A PREVIOUS DAY. LOSS OF CAPTURE WAS ALSO SEEN ON THIS RIGHT VENTRICULAR LEAD AS WELL AS LOW OUT OF RANGE PACING IMPEDANCES. A RIGHT VENTRICULAR LEAD INSULATION ISSUE WAS SUSPECTED. THE RIGHT VENTRICULAR LEAD AND DEVICE WILL BE REPLACED AT A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612643 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R S606| 4136| 4479