BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2041131 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01304
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    March 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT PASSED AWAY THREE WEEKS LATER DUE TO AN UNSPECIFIED REASON. THE DEVICE WAS EXPLANTED AND RETURNED FOR TESTING. UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE FUNCTIONED WITHIN ELECTRICAL SPECIFICATIONS WHEN SUBJECTED TO PACING AND SENSITIVITY TESTING. THE SENSITIVITY WAS TESTED WITH THE DEVICE PACING AT THE LOWER RATE LIMIT AND THE MAXIMUM SENSOR RATE, NO DISCREPANCIES WERE NOTED. SENSITIVITY TESTING WAS ALSO PERFORMED AT THE PARAMETERS NOTED IN THE FIELD AT THE TIME OF THE OBSERVATION, AND TESTED IN SPECIFICATION. THE VISUAL INSPECTION DID NOT REVEAL ANY DISCREPANCIES WITH THE LEAD PORTS OR SET SCREWS. FINAL ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS AS NO DEVICE ISSUES WERE IDENTIFIED. THIS EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS RELEASED THE FOLLOWING DAY AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CAME INTO THE HOSPITAL DUE TO A SYNCOPAL EPISODE. DEVICE EVALUATION NOTED UNDERSENSING AND INAPPROPRIATE PACING. DURING OBSERVATION, TELEMETRY STRIPS SHOWED THE UNDERSENSING AND ADDITIONAL PACING THERAPY APPEARED TO HAVE INDUCED VENTRICULAR FIBRILLATION (VF) AND THE PATIENT REQUIRED AN EXTERNAL SHOCK TO CONVERT. LEAD IMPEDANCE AND THRESHOLDS WERE FINE. THE SENSING WAS REPROGRAMMED TO BIPOLAR, AUTOSENSE WAS PROGRAMMED OFF AND SENSITIVITY WAS REPROGRAMMED TO 0.75MV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S601

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR S601| 4137