BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR

    MDR report key: 1050934 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01873
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 31, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD EXPERIENCE OF BACKUP VVI WAS VERIFIED IN THE LABORATORY. ANALYSIS OF THE DEVICE IMAGE AND TESTING IN THE LABORATORY INDICATES THAT THE BVVI WAS CAUSED BY A HARDWARE ANOMALY WITHIN AN INTEGRATED CIRCUIT COMPONENT.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    AFTER THE INITIAL REPOSITION IN (B) (6) 2007, THE PATIENT REPORTED CHEST PAIN. THE LEAD WAS FOUND TO HAVE FALLEN INTO THE SAME HOLE AS THE INITIAL PERFORATION, CAUSING ANOTHER PERFORATION. THE LEAD WAS EXPLANTED AND REPLACED WITH A PASSIVE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO HARDWARE BACKUP VVI. THE DEVICE WAS REPLACED WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1107-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention