BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2170362 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-11995
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS IN SERVICE. 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCTS REMAIN IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. NO DATE/INITIALS ARE NEEDED HERE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION ONE MONTH LATER THAT DURING AN INVASIVE SURGICAL PROCEDURE, A SETSCREW ISSUE WAS CONFIRMED. ONLY ONE OF THE TWO SETSCREWS WERE TIGHTENED DOWN. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DISPLAYED PACING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS, OVERSENSING AND HIGH THRESHOLD MEASUREMENTS. THE DEVICE OUTPUT WAS INCREASED AND SETSCREW ISSUE WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R T177| 0157| T175