BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUNCTUA

    MDR report key: 2780012 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13429
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 3, 2012
    Report Date
    December 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONTINUED TO EXHIBIT HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN OPTED TO MONITOR THE PATIENT WITH CHEST X-RAY EVERY SIX YEARS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS DETECTED FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS RECENTLY FOLLOWED-UP. A COMMANDED SHOCK WAS PERFORMED TO TEST LEAD INTEGRITY. A 23 JOULE SHOCK WAS DELIVERED, AND THE SHOCK IMPEDANCE REGISTERED AS 74 OHMS. LATITUDE SYSTEM WAS ALSO CHECKED, AND DISPLAYED IMPEDANCE MEASUREMENTS OF SLIGHTLY GREATER THAN 100 OHMS. THE PHYSICIAN DID NOT FEEL ANY FURTHER INTERROGATION WAS NEEDED DUE TO IMPEDANCE MEASUREMENTS BEING WITHIN NORMAL RANGE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. IT WAS CONFIRMED THE ASSOCIATED RV LEAD WAS A COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R F050