BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 4131773 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14400
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    November 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A REVIEW OF THE DEVICE MEMORY CONFIRMED THAT THE PACING IMPEDANCE MEASUREMENTS HAD BEEN BELOW 200 OHMS FOR BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR CHANNELS. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED IN BOTH BIPOLAR AND UNIPOLAR CONFIGURATIONS. THE MEASUREMENTS WERE OUTSIDE OF NORMAL LIMITS, INDICATING AN ANOMALY. AN X-RAY OF THE DEVICE DID NOT SHOW ANY IRREGULARITIES. THE DEVICE CASE WAS OPENED. HIGH POWER VISUAL INSPECTION OF THE INTERNAL CIRCUITRY FOUND A PIECE OF FOREIGN MATERIAL IN CONTACT WITH TWO OF THE CAPACITORS. DETAILED ANALYSIS REVEALED THAT THE FOREIGN MATERIAL WAS CAUSING A HIGH CURRENT DRAIN, RESULTING IN THE CLINICAL OBSERVATIONS. THE FOREIGN MATERIAL WAS TESTED AND CONFIRMED TO BE FROM THE MANUFACTURING PROCESS. THE OBSERVATION/BEHAVIOR HAS BEEN REPORTED TO OUR ENGINEERING AND MANUFACTURING DEPARTMENTS AND WE WILL CONTINUE TO MONITOR FIELD OBSERVATIONS FOR SIMILAR REPORTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THE FINAL SETTING WAS BIPOLAR AND IMPEDANCES REMAINED LOW AND OUT OF RANGE. A REVIEW OF THE ADDITIONAL INFORMATION BY TECHNICAL SERVICES NOTED A POSSIBLE INSULATION ISSUE, ALTHOUGH A ROOT CAUSE WAS NOT DETERMINED DUE TO THE PROVIDED DATA. AN X-RAY WAS ALSO PROVIDED BUT THE PICTURE WAS LOW QUALITY TO SEE THE LOCATION OF THE LEAD. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NEW IMPLANT PROCEDURE ALL MEASUREMENTS ON THE RIGHT VENTRICULAR LEAD WERE WITHIN NORMAL RANGE WHEN MEASURED WITH A PACING SYSTEM ANALYZER (PSA). AFTER THE PROCEDURE THE PACING IMPEDANCES WERE LOW OUT OF RANGE ON THE RIGHT VENTRICULAR LEAD. A FOLLOW UP WAS PERFORMED A WEEK LATER WHICH SHOWED THAT THE RIGHT VENTRICULAR PACING IMPEDANCES REMAINED LOW AND OUT OF RANGE, AND LOSS OF CAPTURE WAS SEEN ON THE RIGHT VENTRICULAR LEAD. DURING A THRESHOLDS TEST, THE RIGHT ARIAL LEAD REVEALED LOSS OF CAPTURE AFTER THE OUTPUTS WERE CHANGED. VARIOUS PROGRAMMING CHANGES WERE MADE WHICH DID NOT RESOLVED THE LOSS OF CAPTURE ON THE RIGHT ATRIAL LEAD. FINALLY THE CONFIGURATION WAS CHANGED TO THE PREVIOUS SETTING AND RIGHT ARIAL LOSS OF CAPTURE WAS RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE DEVICE WAS REPLACED. UPON INSPECTING THE LEADS DURING THE EXPLANT NO ISSUE WAS NOTED. THE LEADS WERE CONNECTED TO A NEW DEVICE. A DEVICE ISSUE WAS SUSPECTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    A FOLLOW UP TOOK PLACE THE ESTIMATED LONGEVITY SHOWED 1.5 YEARS. THE LAST CHECK PERFORMED A FEW DAYS AFTER IMPLANT SHOWED A LONGEVITY OF EIGHT YEARS. THE PHYSICIAN WAS CONSIDERING A SYSTEM REVISION. TECHNICAL SERVICES DISCUSSED PERFORMING SYSTEM EVALUATION WITH PROVIDED MANEUVERS WHICH WOULD HELP TO KNOW THE SYSTEM INTEGRITY AND CAUSE OF THE ISSUE. A SAVE MEMORY OR SAVE ALL WAS RECOMMENDED FOR A THOROUGH SYSTEM EVALUATION. A FOLLOW UP WAS PERFORMED, IMPEDANCES WERE LOW AND OUT OF RANGE ON BOTH ATRIAL AND VENTRICULAR CHANNEL. A SAVE TO MEMORY WAS PERFORMED. IT WAS NOTED THAT THE DEVICE WAS USED 375% POWER ON THE POWER CONSUMPTION, WHICH IS LIKELY THE REASON FOR THE DISPLAYED LONGEVITY. THE DEVICE WAS PROGRAMMED TO AAI. A PATIENT FOLLOW UP WAS SCHEDULED. A SAVE TO MEMORY WAS SENT TO TECHNICAL SERVICES FOR REVIEW. A REVIEW BY ENGINEERING OF THE SAVE TO MEMORY NOTED THAT THE DEVICE HAD NO RESETS OR FAULTS. IT WAS NOTED THAT THE LEADS MAY BE SHORTED RESULTING IN OUT OF RANGE LOW PACING IMPEDANCES. THE LOW PACING IMPEDANCES HAVE AFFECTED DEVICE LONGEVITY. A SYSTEM REVISION WAS DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612688 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J176

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR J176| 4480| 4457