BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 4140468 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17342
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXPERIENCED APPROXIMATELY 50 INAPPROPRIATE SHOCKS DUE TO A RIGHT VENTRICULAR (RV) LEAD FRACTURE. THE PATIENT HAD EXPERIENCED THERAPY EXHAUSTION AS A RESULT OF THE INAPPROPRIATE SHOCK THERAPY. IT WAS BELIEVED THAT THE FRACTURE WAS DUE TO SUBCLAVIAN "CRUCH". THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE LEAD WAS SURGICALLY CAPPED AND THIS ICD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618187 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R D176| 0181| 0692| T167| 4244