BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1950563 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22738
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    February 3, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, ANALYSIS CONFIRMED THAT THE DEVICE CASE WAS INSPECTED, NO DENTS, BUT SOME ELECTROCAUTERY DAMAGE WAS NOTED. THE DEVICE WAS OPENED, AND THE BATTERY VOLTAGE (2.69V) AND CURRENT (7.9UA) WERE ALL NORMAL. THERE WAS AN INSPECTION OF THE HYBRID AND COMPONENTS INCLUDING THE U6 COMPONENT, IT WAS NOTED THAT CRACKS WERE FOUND IN THE SOLDER JUNCTION 4 PINS, AND ALL 4 CORNER PINS OF THE U6 COMPONENT SHOW SOME CRACKS. THE U6 COMPONENT WAS PROBED FOR RESISTANCE, TEST POINTS 14(AR3) TO 15(AR2) WHICH INDICATES AN INTERMITTENT READING. THE DEVICE CASE SHOWS TOOL MARKS AND ELECTROCAUTERY DAMAGE. IT IS BELIEVED THAT THE DAMAGE TO THE U6 COMPONENT COULD BE INDUCED, BASED ON CONDITION OF CASE. THE DEVICE PACED AND PROVIDED CRITICAL THERAPY, BUT DID NOT SENSE CORRECTLY IN ATRIUM ONLY.

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY IT WAS NOTED THAT THIS DEVICE FAILED RETURN PRODUCT TESTING (RPT) FOR STORED E GRAMS (12-3,4) AND SENSITIVITY (14-1) TESTING. TESTS 1-11 OF RPT PASSED (TOTAL OF 16 TESTS). THIS DEVICE FAILED MANUAL TESTING OF SENSITIVITY OF ATRIUM BY NOT INHIBITING PACE AT PROGRAMMED SETTINGS. ALL OTHER MANUAL TESTING THIS DEVICE UNDERWENT, HAD PASSED. THE CASE WAS INSPECTED, NO DENTS, BUT SOME EC DAMAGE WAS NOTED. THE DEVICE WAS OPENED , BATTERY VOLTAGE (2.69V) AND CURRENT (7.9UA) WERE NORMAL. THE DEVICE WAS INSPECTED ON HYBRID AND COMPONENTS INCLUDING U6 WAS PERFORMED. A CRACK IN 1 SOLDER JUNCTION WAS NOTED ON U6. NO EVIDENCE OF ADVISORY ISSUES WAS FOUND IN MEMORY OR OPERATION OF DEVICE. THE DEVICE PACED AND PROVIDED CRITICAL THERAPY, BUT DID NOT SENSE CORRECTLY, BUT DID NOT SENSE CORRECTLY IN ATRIUM ONLY.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DID NOT PASS STORED EGRAMS TEST PORTION OF THE RETURNED PRODUCTS TESTING, SUGGESTING A POSSIBLE PERFORMANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 1298| 4039| 4457| S603