BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3211651 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08230
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. THIS DEVICE AND THE CHRONIC LEADS WERE LATER EXPLANTED DUE TO THE EROSION, AND A NEW, COMPETITIVE DEVICE AND LEAD SYSTEM WERE IMPLANTED ON THE PATIENT'S OTHER SIDE. NO RETURN OF EXPLANTED PRODUCTS IS EXPECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. 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

    A REQUEST WAS MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE STATUS OF THE DEVICE IS NOT KNOWN. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED TO A HOSPITAL BECAUSE THE DEVICE WAS EXPOSED THROUGH THE PATIENT'S SKIN. THE PHYSICIAN BELIEVED EITHER AN INFECTION OR ALLERGIC REACTION CAUSED THE EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310928 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F163

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R