BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4180219 · Received October 15, 2014

    Report

    Report Number
    3009448963-2014-00275
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    December 26, 2013
    Report Date
    September 18, 2014
    Manufacturer
    CAMERON HEALTH INC.
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE PRESENTED TO THE HOSPITAL WITH NAUSEA AND VOMITING. THE PATIENT WAS DIAGNOSED WITH HYPERTHYROIDISM. AND WAS HOSPITALIZED FOR 13 DAYS. THE PATIENT UNDERWENT FURTHER TESTING FOR THEIR CONDITION. IT WAS LATER REPORTED THAT THE PATIENT LOST A SIGNIFICANT AMOUNT OF WEIGHT AND THE S-ICD WAS ERODING THROUGH THE PATIENT'S SKIN. THE DEVICE AND ELECTRODE WERE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653613 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH INC. 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4)