BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 4131694 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14673
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 AND RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE HOSPITAL FOLLOWING SYNCOPAL EPISODES. REVIEW OF STORED DEVICE MEMORY REVEALED EPISODES OF OVERSENSING THAT RESULTED IN PACING INHIBITION, UNDERSENSING AND OCCASIONAL CONDUCTED BEATS WITH SOME FUSION. ADDITIONALLY, RV THRESHOLD MEASUREMENTS WERE NOTED TO HAVE INCREASED, R-WAVE MEASUREMENTS HAD DECREASED AND TELEMETRY NOISE WAS OBSERVED ON ALL CHANNELS. THE PATIENT HAD LOST WEIGHT AND THE DEVICE WAS NOTED TO HAVE MIGRATED IN THE POCKET, HOWEVER, NO EVIDENCE OF LEAD MOVEMENT OR TWISTING WAS OBSERVED. THE DEVICE WAS REPROGRAMMED TO VVI AT A FIXED OUTPUT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613152 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4135| 4136| S606