BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 1913846 · Received December 3, 2010

    Report

    Report Number
    2124215-2010-23211
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    September 17, 2010
    Report Date
    November 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE AND NO ANOMALIES WERE FOUND. THIS DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS, OPERATING AS DESIGNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT APPROXIMATELY 38 HOURS POST IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM UNCONSCIOUS AND UNRESPONSIVE; THE PATIENT SUBSEQUENTLY PASSED AWAY. THE CORONER INITIALLY SPECULATED THAT THE PATIENT HAD AN ACUTE MYOCARDIAL INFARCTION DUE TO CALCIFICATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PACEMAKER WAS RETURNED TO BOSTON SCIENTIFIC WITH A FORM FROM THE MEDICAL EXAMINER'S OFFICE THAT LISTED THE CAUSE OF DEATH AS NATURAL WITH POSSIBLE CARDIAC TAMPONADE. THE SALES REPRESENTATIVE NOTED THAT AT THE TIME OF THE IMPLANT PROCEDURE THIS PATIENT HAD COMPLETE HEART BLOCK WITH AN ESCAPE RATE AND ALL LEAD DIAGNOSTICS WERE WITHIN NORMAL RANGE PRIOR TO DISCHARGING THE PATIENT. IT WAS ALSO NOTED THAT WHILE PLACING THE RIGHT VENTRICULAR (RV) LEAD THE PHYSICIAN UTILIZED THE FIRST LOCATION AND THE CHEST X-RAY TAKEN PRIOR TO DISCHARGE SHOWED GOOD LEAD PLACEMENT. TWO MONTHS LATER, THE MEDICAL EXAMINER STATED THAT THERE WAS AN INDICATION THAT THE PATIENT HAD A CARDIAC TAMPONADE DUE TO A PERFORATED CARDIAC APEX AS A COMPLICATION OF LEAD PLACEMENT. THE FINAL CAUSE OF DEATH IS LISTED AS CARDIAC TAMPONADE. THERE WERE NO SPECIFIC FIELD ALLEGATIONS AGAINST THE PACEMAKER. THE INVESTIGATION IS COMPLETE AT THIS TIME.

    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 76 YR Death| H| L| R S606| 4469| 4136