BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2911880 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16347
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    March 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED MECHANICAL AND ELECTRICAL TESTING OF THE DEVICE WAS PERFORMED. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. ANALYSIS CONCLUDED THIS DEVICE DID NOT EXPERIENCE A COMPONENT MALFUNCTION OR PREMATURE BATTERY DEPLETION, AND REPLACEMENT INDICATORS WERE DISPLAYED APPROPRIATELY RELATIVE TO THE ACTUAL BATTERY CONDITION. HOWEVER, SERVICE LIFE FELL SLIGHTLY SHORT OF LONGEVITY EXPECTATIONS AS OUTLINED IN THE INSTRUCTIONS FOR USE ORIGINALLY APPROVED FOR AND DISTRIBUTED WITH THIS DEVICE. LONGEVITY CALCULATORS HAVE SINCE BEEN REFINED TO BETTER REFLECT ACTUAL DEVICE PERFORMANCE AND CURRENT CLINICAL PRACTICES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE EXPERIENCED SYNCOPE. DURING FOLLOW UP, THE HEALTH CARE PROVIDER INDICATED THAT THE DEVICE HAD BEEN FUNCTIONING APPROPRIATELY AND THERE WAS NO EVIDENCE OF LOSS OF CAPTURE. THE CAUSE OF THE PATIENT'S SYNCOPE WAS UNKNOWN. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, THE DEVICE WAS EXPLANTED FOR ELECTIVE REPLACEMENT INDICATOR (ERI). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE DEVICE WAS EXPLANTED FOR AN UNKNOWN REASON. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16403 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening 1290| 5024M| 4058M| 294-05