BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4172536 · Received October 10, 2014

    Report

    Report Number
    3009448963-2014-00265
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT ONE DAY POST-IMPLANT, A TELEMETRY ANOMALY WAS EXHIBITED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). INTERNAL ENGINEERS AND THE LOCAL FIELD REP DISCUSSED A THOROUGH STEP-BY-STEP APPROACH, ATTEMPTING TO REESTABLISH TELEMETRY, THE PT REMAINED HOSPITALIZED UNDER MEDICAL SUPERVISION DURING ROOT CAUSE ASSESSMENT, AS THERAPY COULD NOT BE GUARANTEED. EXHAUSTIVE EFFORTS CONFIRMED NO EXTERNAL INTERFERENCES AND NO ISSUES WITH ANY ASSOCIATED PROGRAMMERS. DATA FILES WERE FORWARDED FOR REVIEW; BOSTON SCIENTIFIC'S ENGINEERS MADE THE RECOMMENDATION TO EXPLANT THE DEVICE AND RETURN THE PRODUCT FOR ANALYSIS. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADVERSE EFFECT WERE REPORTED DURING THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643423 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 3010