BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 4140009 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17306
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2004
    Report Date
    September 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    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 THIS DEVICE WITH RIGHT VENTRICULAR LEAD DISPLAYED FAR-FIELD OVERSENSING AND PACING INHIBITION. THE PATIENT WITH THIS DEVICE IS PACEMAKER DEPENDENT, HOWEVER IT IS UNKNOWN WHETHER THERE WAS ASYSTOLE AS A RESULT OF THIS ISSUE. A REVISION PROCEDURE WAS PERFORMED. THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED. THIS DEVICE REMAINED IMPLANTED AND RECONNECTED TO THE REPLACEMENT DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620693 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND 1853

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R 0158| 4017| 4087| 0155| 1861| 1853