BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152448 · Received June 24, 2014

    Report

    Report Number
    3009448963-2014-00128
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    August 1, 2013
    Report Date
    June 2, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS INCIDENT IS STILL CURRENTLY ONGOING. ONCE ANY FURTHER INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE EXPERIENCED AN INFECTION. THE S-ICD WAS EXPLANTED AND THEN RE-IMPLANTED. NO ADDITIONAL ADVERSE PT EFFECTS WERE REPORTED. CLOSE TO ONE YEAR LATER, ADDITIONAL INFO WAS RECEIVED THAT IT IS BELIEVED THAT THE PT IS EXPERIENCING A HYPERSENSITIVITY TO THE ACTUAL DEVICE. AT THIS TIME, THE S-ICD REMAINS IMPLANTED. THE SERIAL NUMBER IS CURRENTLY UNK. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO HAVE SO FAR BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367631 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

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