BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3050125 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03482
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    May 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. THE DEVICE HAD NO TELEMETRY; THEREFORE, THE MEMORY DOWNLOAD AND LONGEVITY CALCULATION COULD NOT BE PERFORMED. THE DEVICE HAD NO PACING OUTPUT IN EITHER BIPOLAR OR UNIPOLAR LEAD CONFIGURATION. THE BATTERY WAS FOUND TO BE DEPLETED TO THE POINT WHERE IT COULD NO LONGER SUPPORT PACING, TELEMETRY OR MEMORY FUNCTIONS. THE HYBRID WAS FOUND TO HAVE A HIGH CURRENT WITH EXTERNAL POWER ATTACHED. DURING TROUBLESHOOTING THE HIGH CURRENT WENT AWAY. SEVERAL TECHNIQUES WERE USED IN AN ATTEMPT TO GET THE HIGH CURRENT DRAIN BACK, BUT NONE WERE SUCCESSFUL. A FEW COMPONENTS WERE INDIVIDUALLY TESTED THAT COULD CAUSE THE HIGH CURRENT, BUT THEY WERE WITHIN SPECIFICATION. THE HYBRID PASSED THE AUTOMATED PRODUCTION HYBRID TEST, INCLUDING ALL CURRENT DRAINS TESTED. THE CAUSE OF THE HIGH CURRENT DRAIN AND SUBSEQUENT PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED ONCE THE HIGH CURRENT WENT AWAY.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, IT WAS NOT POSSIBLE TO ESTABLISH TELEMETRY. ADDITIONALLY, THERE WAS NO MAGNET RESPONSE. AS A RESULT, A DEVICE REPLACEMENT PROCEDURE WAS SCHEDULED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150245 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S203

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R