BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 757086 · Received August 30, 2006

    Report

    Report Number
    2938836-2006-00686
    Event Type
    Injury
    Date Received
    August 30, 2006
    Date of Event
    July 13, 2006
    Report Date
    August 21, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD. LABELING: DEVICE CODE - 2574, 2575 - LABLED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS REPLACED DUE TO CHANGE IN THRESHOLDS AND R-WAVES. DURING THE LEAD REPOSITION, THE HELIX WOULD NOT RETRACT OR EXTEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC. CRMD 700/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention