BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 6717598 · Received July 17, 2017

    Report

    Report Number
    2124215-2017-12055
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    June 14, 2017
    Report Date
    June 14, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    UDI-DI
    00802526584404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS FIELD CLINICAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES. THE PATIENT WAS SEEN IN-CLINIC FOR POST-IMPLANT CHECK. THE PHYSICIAN HAD UTILIZED A TWO INCISION TECHNIQUE. THE PHYSICIAN HAD USED A MEDICAL ZIPLINE PRODUCT FOR THE POCKET AND XYPHOID SITES. THE PHYSICIAN THOUGHT THAT THE SITES WERE INFECTED BUT ONCE THE PATIENT WAS TAKEN TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE SITES WERE CLEANED WITH NO SIGNS OF INFECTION. THE INCISIONS WERE PARTIALLY CLOSED. THE ZIPLINE PRODUCTS WERE REMOVED AND THE PHYSICIAN CLOSED THE SITES WITH STERI-STRIPS. THE PATIENT MEDICAL HISTORY WAS SIGNIFICANT FOR SARCOIDOSIS AND WAS ON PREDNISONE. CULTURES WERE SENT FOR ANALYSIS. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE FIELD CLINICAL REPRESENTATIVE DID NOT HAVE ACCESS TO THE CULTURE RESULTS. NO FURTHER INTERVENTION WAS REQUIRED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497943 S-ICD SYSTEM LWS GUIDANT CRM CLONMEL IRELAND A219 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R 3401| A219