BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1951050 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24186
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    August 9, 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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    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. THE OBSERVATION WAS CONFIRMED BY INDICATIONS IN MEMORY. THE ATRIAL CHAMBER OVER SENSING AND VARYING LEAD IMPEDANCES ARE NOT THE RESULT OF A DEVICE MALFUNCTION. THE DEVICE MEETS SPECIFICATION. THE REASON FOR EXPLANT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS FOR AN UNKNOWN REASON. THE DEVICE WAS REPROGRAMMED TO VVI 70. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED BY THE RETURNS LABORATORY WITHOUT EXPLANT PAPERWORK. THE REASON FOR THE EXPLANT IS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE BOSTON SCIENTIFIC SALES REPRESENTATIVE DISCUSSED THE SITUATION WITH THE CLINIC AND FOUND THAT THERE HAS NOT BEEN A SURGICAL INTERVENTION SCHEDULED FOR THIS PATIENT AND THE DEVICE REMAINS PROGRAMMED TO VVIR 70. THERE HAS BEEN NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 4456| 4469| S403