BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4851615 · Received June 17, 2015

    Report

    Report Number
    2938836-2015-26689
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    April 13, 2015
    Report Date
    April 13, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP HIGH CAPTURE THRESHOLDS WERE OBSERVED. PATIENT WAS ASYMPTOMATIC. THE LEAD WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393274 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7120/65 2771691

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention