BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA

    MDR report key: 4893525 · Received July 6, 2015

    Report

    Report Number
    2938836-2015-27455
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RELATED COMPLAINT RECEIVED WITH RETURN OF DEVICE. CONCLUSION: FAILURE OBSERVED DURING ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 14.7-14.9CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION. EXTERNAL INSULATION ABRASION WAS NOTED AT 42.0-42.3CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AT THIS LOCATION.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434705 RIATA DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7001/65

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR