BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1950433 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22696
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES (TS) WAS CONSULTED AND REFERRED THE PATIENT TO THEIR PHYSICIAN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A SYNCOPAL EPISODE THAT WAS REPORTED BY THE PATIENT'S WIFE. SHE NOTED THAT THE PATIENT PASSED OUT WHILE EXERCISING ON THE TREADMILL AND SCRAPED HIS KNEE'S. IT WAS REPORTED THAT THE DEVICE HAD PREVIOUSLY BEEN CHECKED BY THE FIELD REPRESENTATIVE WHO HAD DECREASED THE PACING OUTPUTS. POST SYNCOPE THE PATIENT UNDERWENT A DEVICE REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 4087| 4035| S606| 1298