BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2173770 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10952
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 24, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILBALE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE DEVICE HAS NOT BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE DEVICE WAS EXPLANTED. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PULSE GENERATOR EXPECTED THE DEVICE WOULD LAST 5 YEARS BUT DUE TO HOW IT WAS PROGRAMMED THE DEVICE LASTED 3.5 YEARS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1194

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention (B)(4)| (B)(4)