BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 1073069 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02315
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE ANALYSIS CONFIRMED THE NOISE ANOMALY. THE NOISE AND HIGH IMPEDANCE WAS TRACED TO THE HYBRID SUB-ASSEMBLY. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE FAILURE MODE WAS LOST DURING THE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RV COIL TO CAN, RV TO SVC, AND SVC TO CAN. OUT OF RANGE HVLI MEASUREMENTS OCCURRED WHEN THIS NOISE WAS OBSERVED ON THE IEGMS. THE PHYSICIAN OPENED THE POCKET AND CONNECTIONS LOOKED GOOD; HOWEVER, ALL WERE RE-TIGHTENED. NO PROBLEMS WERE OBSERVED ON THE LEADS. THE DEVICE WAS REMOVED WHEN THE OVERSENSING CONTINUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DECEASED. IT WAS NOTED THAT THE LEAD EXHIBITED A MECHANICAL PROBLEM. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention