BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3961713 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-14506
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS HOSPITALIZED AFTER EXPERIENCING SYNCOPE FOR AN UNKNOWN REASON. DURING THE DEVICE INTERROGATION THE PHYSICIAN WAS UNABLE TO OBTAIN R-WAVE AMPLITUDE MEASUREMENTS EVEN AFTER TROUBLESHOOTING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED OTHER TROUBLESHOOTING OPTIONS. IT WAS NOTED THAT THE DAILY MEASUREMENT FOR THE R WAVES HAS BEEN AROUND 10 MILLIVOLTS. THE PHYSICIAN STATED THAT HE WOULD ATTEMPT TO RUN THE AMPLITUDE TEST AGAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439258 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S208

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L S208| 4137| 4136