BEUDAMED
    FDA Adverse Event Injury Summary report: N

    033-654 OSCOR

    MDR report key: 8595488 · Received May 9, 2019

    Report

    Report Number
    2938836-2019-03572
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 9, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI NOT AVAILABLE AS PRODUCT WAS MANUFACTURED BEFORE 9/23/2014. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOSS OF CAPTURE AND PACING IMPEDANCE, OUT OF RANGE, ISSUE WERE OBSERVED ON THE RV LEAD. CAPTURE THRESHOLD WAS INCREASING AND PROGRESSING TO LOSS OF CAPTURE. THE PATIENT WAS DEPENDENT. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2019. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389007 033-654 OSCOR PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 033-654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention