BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 3812648 · Received May 6, 2014

    Report

    Report Number
    3009448963-2014-00046
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    September 5, 2013
    Report Date
    April 24, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 PT RECEIVED AN INAPPROPRIATE SHOCK FROM THEIR SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SHORTLY AFTER BEING DISCHARGED FROM THE HOSP FOLLOWING THE IMPLANT PROCEDURE. A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PT WAS BROUGHT BACK TO THE EMERGENCY ROOM AFTER COLLAPSING AND REPORTS THE PT COLLAPSED DUE TO INCORRECT PROGRAMMING IN THE DEVICE. A REVIEW OF STORED EPISODES SHOWED SOME NON-TREATED AND TREATED EVENTS DUE TO OVERSENSING NOISE. THE ISSUE WAS BEING ATTRIBUTED TO AIR BUBBLES IN THE POCKET. AT A POST-PO FOLLOW-UP APPOINTMENT, THE ISSUE WAS UNABLE TO BE RECREATED. THE ISSUE RESOLVED WITH REPROGRAMMING A DIFFERENT VECTOR. NO ADDITIONAL ISSUES OR ADDITIONAL ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271583 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 3010