BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 754654 · Received August 21, 2006

    Report

    Report Number
    2938836-2006-00666
    Event Type
    Injury
    Date Received
    August 21, 2006
    Date of Event
    August 14, 2006
    Report Date
    August 14, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON STERIS'S INVESTIGATION OF THE SYSTEM 1 PROCESSOR IN QUESTION, THE LID CLOSED DUE TO A FAILURE OF THE GAS/SPRING CYLINDER ON THE PROCESSOR LID. THE GAS CYLINDER FUNCTIONS TO GRADUALLY OPEN THE PROCESSOR LID AND HOLD THE LID OPEN WHILE LOADING/UNLOADING THE PROCESSING CHAMBER. AN EVALUATION OF THE GAS/SPRING CYLINDER ON THE PROCESSOR IN QUESTION INDICATES THAT THE STEEL SHAFT HAD BROKEN NEAR THE POINT OF ATTACHMENT TO THE LID. UNDER CERTAIN CONDITIONS THIS FAILURE COULD CAUSE THE LID TO CLOSE UNEXPECTEDLY. THE OPERATOR INVOLVED IN THE INCIDENT INDICATED TO STERIS THAT THE CYLINDER HAD SHOWN SIGNS OF DETERIORATION PRIOR TO THIS INCIDENT IN THAT THE GAS/SPRING CYLINDER WAS NOT CORRECTLY OPENING AND HOLDING THE LID IN THE OPEN POSITION. BASED UPON AN ANALYSIS OF COMPLAINTS OVER THE LAST 4 YEARS ON AN INSTALLED BASE OF OVER 10,000 SYSTEM 1 PROCESSORS AND OVER 50,000,000 PROCESSING CYCLES, THIS IS THE ONLY OPERATOR INJURY ASSOCIATED WITH BREAKAGE OF THE GAS SPRING CYLINER SHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO CAPTURE PRESENT AT THE PROGRAMMED SETTINGS. A SENSING ANOMALY WAS ALSO NOTED. THE ISSUE WILL BE RESOLVED BY REPOSITIONING THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION LEAD DEFIBRILLATION LEAD DTB ST. JUDE MEDICAL, INC., CRMD 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention