BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1954184 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24295
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, INITIAL TESTING REVEALED NORMAL INTERROGATION AND TELEMETRY OPERATIONS. THE DEVICE WAS SUBJECTED TO A LONGEVITY CALCULATION BASED ON SYSTEM GUIDE LABELING FOR THIS MODEL DEVICE AND WAS FOUND TO NOT MEET LONGEVITY. DESIGN ENGINEERS HAVE NOTED DEFICIENCIES IN THIS CALCULATION AND DETERMINED THAT IT DOES NOT ACCURATELY REPRESENT THE DEVICE'S BATTERY PERFORMANCE. AS A RESULT, THE DEVICE LONGEVITY WAS TESTED A SECOND TIME, USING A REVISED LONGEVITY CALCULATOR THAT HAS CORRECTED THE DEFICIENCIES OF THE ORIGINAL CALCULATOR. THIS DEVICE PASSED THE SECOND LONGEVITY CALCULATION. ANALYSIS CONCLUDED THIS DEVICE DID NOT EXPERIENCE A COMPONENT ANOMALY OR PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    ONCE ANALYSIS IS COMPLETE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE PACEMAKER DECLARED THE BATTERY STATUS ELECTIVE REPLACEMENT INDICTORS (ERI) AND WAS EXPLANTED. THERE IS AN ASSOCIATED ALLEGATION OF PREMATURE BATTERY DEPLETION. THIS DEVICE IS INTENDED TO BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY THIS DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1190

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 1130| 1190| 4271| 0940| 4261