BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIENT

    MDR report key: 3053269 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04168
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ANY ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS PER THE HOSPITAL'S POLICY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH PACING THRESHOLD MEASUREMENTS HAVE BEEN NOTED SINCE THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED. A PATIENT FOLLOW-UP WAS PERFORMED AFTER THE PATIENT RECEIVED MULTIPLE SHOCKS. WHEN THE DEVICE WAS INTERROGATED, THE PROGRAMMER DETECTED THE DEVICE AS A DIFFERENT MODEL AND A WARNING MESSAGE WAS DISPLAYED INDICATING THAT A DEVICE FAULT HAS OCCURRED. A REQUEST FOR REVIEW WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). A TS CONSULTANT DISCUSSED THAT A RAM FAILURE IN THE MEMORY HAD OCCURRED AND THE ICD WAS IN FALLBACK MODE. A MEMORY DOWNLOAD WAS REQUESTED AND AN IMMEDIATE DEVICE REPLACEMENT WAS DISCUSSED. IT WAS INDICATED THAT THE DEVICE CAN NOT BE RETURNED FOR ANALYSIS DUE TO COUNTRY LIMITATIONS AND A MEMORY DOWNLOAD WAS TO BE OBTAINED FOR FURTHER REVIEW BY ENGINEERING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A MEMORY DOWNLOAD WAS UNABLE TO BE PERFORMED WITH THE DEVICE IN FALLBACK MODE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157002 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F030

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R F030| 4096| 0185