BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2060141 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05860
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 25, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING PRODUCT RETURN AND COMPLETION OF LAB ANALYSIS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RETURN, THIS DEVICE WAS THOROUGHLY ANALYZED. ENGINEERS CONFIRMED NORMAL TELEMETRY OPERATIONS AND AN ABSENCE OF HARDWARE RESETS. AN X-RAY IMAGE CONFIRMED NO FRACTURED FEED THRU WIRES AND THE DEVICE SENSED AND PACED NORMALLY DURING TESTING OPERATIONS WITH NO PAUSES IN PACING OBSERVED WHILE MANIPULATING THE HEADER. VISUAL INSPECTION NOTED MEDICAL ADHESIVE (MA) WAS ADHERED TO THE DEVICE HEADER; HOWEVER, MINIMAL MA WAS OBSERVED ON THE DEVICE CASE ITSELF; HEADER CONFIRMED LOOSE. THE LABORATORY CONFIRMED ANOMALY, HAS BEEN CLASSIFIED INTO AN EXISTING PATTERN ADDRESSING THIS CONCERN WITH CORRECTIVE ACTIONS INITIATED AFTER THE MANUFACTURING DATE OF THIS PRODUCT. TO DATE, THE IMPLEMENTED CORRECTIVE ACTION HAVE BEEN PROVEN EFFECTIVE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS BEING REPLACED FOR NORMAL BATTERY DEPLETION; HOWEVER, DURING SYSTEM INTERROGATION PRIOR TO THE PROCEDURE, NOISE ON THE RIGHT VENTRICULAR LEAD CHANNEL WAS EXHIBITED. DURING THE EXTRACTION PROCEDURE THE PHYSICIAN NOTED A LOOSE HEADER AND ATTRIBUTED THE CLINICAL OBSERVATION TO THIS ANOMALY. AFTER FAVORABLE MEASUREMENTS WERE OBTAINED WITH A NEW DEVICE, SYSTEM NOISE WAS AGAIN OBSERVED AND THE ASSOCIATED RIGHT VENTRICULAR THEN SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND ANOTHER DEVICE AND RIGHT VENTRICULAR LEAD WERE SUCCESSFULLY IMPLANTED. THE EXPLANTED DEVICE IS TO BE RETURNED FOR A POST MARKET ASSESSMENT.

    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