BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4203076 · Received October 23, 2014

    Report

    Report Number
    3009448963-2014-00290
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 2, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    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 WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM RECEIVED INAPPROPRIATE SHOCK THERAPY. IT WAS DETERMINED THE ELECTRODE HAD DISLODGED AND THAT THE DEVICE HAD MIGRATED. SUBSEQUENTLY A THIRD UNTREATED EPISODE WAS IDENTIFIED AND WAS DETERMINED TO BE DUE TO OVERSENSING. UNDERSENSING WAS ALSO NOTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE BOTH THE ELECTRODE AND DEVICE WERE REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674972 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| R 1010