BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3020591 · Received March 21, 2013

    Report

    Report Number
    3009448963-2013-00020
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 15, 2011
    Report Date
    March 5, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFO DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT WITH THIS DEVICE AND ELECTRODE EXPERIENCED POSTOPERATIVE DISCOMFORT. ONE MONTH LATER, THE PT HAD DEVELOPED PAIN AT THE WOUND SITE AND REDNESS DUE TO AN INFECTION. MEDICAL INTERVENTION WAS PERFORMED, AND THE PT WAS PUT INTO A LIFE VEST UNTIL THE ISSUE WAS RESOLVED. APPROXIMATELY 1.9 YEARS LATER, ADDITIONAL INFO WAS RECEIVED AT THIS DEVICE WAS EXPLANTED FOR AN EROSION. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED. THE PT WAS PUT INTO A LIFE VEST. THE ELECTRODE REMAINS IMPLANTED. ADDITIONAL INFO WAS PROVIDED THAT DURING AN INTERNAL REVIEW OF THE LOG FILES NOTED THAT AN ALERT WAS TRIGGERED ON THIS DEVICE, AS A RESULT OF THERAPY BEING DISABLED. IT WAS ALSO REPORTED THAT THE IMPEDANCES WERE HIGH ON THE ELECTRODE. THE DEVICE EXPLANT THAT OCCURRED ONE MONTH EARLIER WAS MOST LIKELY THE REASON FOR THE ALERT AND HIGH IMPEDANCE VALUES. FURTHER INVESTIGATION INTO THIS ISSUE IS CURRENTLY BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118212 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 1010,3400