BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1951630 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24750
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH DEVICE EVALUATION WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE HEADER WAS LOOSE FROM THE DEVICE. ADDITIONALLY, MEDICAL ADHESIVE WAS ADEQUATE AND STILL ATTACHED TO THE HEADER AND THERE WAS NO EVIDENCE OF INDUCED MECHANICAL FAILURE. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. THE DEVICE MALFUNCTION IS MECHANICAL IN NATURE AND ELECTRICALLY, THE DEVICE WAS WITHIN NORMAL SPECIFICATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE PROCEDURE TO REPLACE THIS PACEMAKER, THE HEADER WAS FOUND TO BE LOOSE. A COMPETITVE DEVICE WAS IMPLANTED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR MISMATCH| 1388TC| 1488TC| 1297