BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIENT

    MDR report key: 2042412 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-04926
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPRESENTATIVE WAS UNSURE IF THE HOSPITAL WOULD RETURN THE PRODUCTS. INVESTIGATION IS COMPLETED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TRANSVENOUS LEAD UNDERWENT LUMBAR BACK SURGERY FOR OSTEOMYELITIS ON THEIR VERTEBRAE. THERE WAS CONFIRMED VEGETATION ON THEIR LEADS AND THOUGHT THAT THIS PATIENT MIGHT HAVE A SYSTEMIC INFECTION. ALL PRODUCTS WERE REMOVED FROM SERVICE. NO FURTHER PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention V-168| E030| 4135| 7011