BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3904753 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11780
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT IMPLANTED WITH THIS PACEMAKER WAS HOSPITALIZED DUE TO POSSIBLE VENTRICULAR TACHYCARDIA (VT) NOTED ON TELEMETRY STRIPS AT THE CLINIC. IT WAS DETERMINED TO BE THERAPY INDUCED HIGH RATE PACING. THE FIELD REPRESENTATIVE CONSULTED WITH THE PHYSICIAN AND NO FURTHER ACTION WAS TAKEN. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383354 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R 4136| S606| 4135