BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 1735945 · Received June 24, 2010

    Report

    Report Number
    2124215-2010-13179
    Event Type
    Death
    Date Received
    June 24, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER PATIENT DIED. MEASUREMENTS WERE REPORTED AS STABLE SINCE IMPLANT; HOWEVER, THE PATIENT BECAME SEPTIC POST-IMPLANT. APPROXIMATELY TWO MONTHS POST-IMPLANT, A VENTRICULAR PACING FAILURE OCCURRED AT MAXIMUM OUTPUT (6.5V/1MS). AMPLITUDE AND THRESHOLD VALUES HAD ALSO WORSENED. REPORTEDLY, X-RAYS INDICATED A POTENTIAL MICRO-DISLODGMENT OF THE RV LEAD. ALTHOUGH THE PATIENT'S CONDITION WAS NOTED TO BE VERY POOR, THE PHYSICIAN SUGGESTED A LEAD REPOSITIONING PROCEDURE (AS THE RV LEAD HAD BEEN POSITIONED ON THE INTERVENTRICULAR SEPTUM), BUT THE PATIENT'S HUSBAND REFUSED DUE TO HER POOR PROGNOSIS. IT WAS REPORTED THAT THE PHYSICIAN DID NOT ATTRIBUTE THE PATIENT'S DEATH TO A PRODUCT-RELATED ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death