BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 7977848 · Received October 18, 2018

    Report

    Report Number
    2124215-2018-17790
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    July 11, 2018
    Report Date
    October 17, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    ANALYSIS CONFIRMED DEVICE DID NOT TRIGGER REPLACEMENT INDICATOR WHILE IMPLANTED AND FAILED RETURNED PRODUCT TEST. LAB COMPLETED ADDITIONAL TESTING; NORMAL TELEMETRY WHEN INTERROGATED BY ZOOM PROGRAMMER, RETURNED PRODUCTS TEST WAS PASSED THE SECOND TIME, NO VISUAL IRREGULARITIES, AND NORMAL DEVICE OPERATION WAS NOTED DURING TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS EXPLANTED. THIS DEVICE NEAR OR REACHED ERI AND WAS REQUIRED TO BE CHANGED OUG. THE RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED FOR UNKNOWN PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818495 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 1290| 4457| 4480| 5076| 7742| L301| S606