BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 4140039 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16724
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    December 6, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    (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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS LATER EXPLANTED AND REPLACED 2 YEARS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER SHOWED A BATTERY STATUS OF SIX MONTHS REMAINING. A PRINTED REPORT FROM INTERROGATION WITH A PROGRAMMER SHOWED A BATTERY STATUS OF 1.5 YEARS REMAINING. IT WAS REPORTED THAT THE BATTERY STATUS SHOWED ONE YEAR REMAINING APPROXIMATELY SIX MONTHS AGO. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED BATTERY STATUS CHANGES AND POTENTIAL AFFECTING FACTORS. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN WILL CONTINUE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620725 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4136| S603