BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4997335 · Received August 12, 2015

    Report

    Report Number
    2938836-2015-28656
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    February 26, 2015
    Report Date
    July 20, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE RETRACT THIS MDR 2938836-2015-0053698. THE ORIGINAL COMPLAINTS ARE FOUND TO BE RELATED AND REPORTED TO THE ATRIAL LEAD RECORD 2938836-2015-0112723, NOT THE RIGHT VENTRICULAR LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED FOR A PROCEDURE SINCE THE LEAD WAS NOT WORKING. THE PHYSICIAN ATTEMPTED TO REATTACH THE LEAD. THE PATIENT REPORTED HAVING SHORTNESS OF BREATH. THE PATIENT WAS ADDRESSED BY WITH MEDICINE TO COUNTER THE DEVICE NOT PROPERLY MAINTAINING THE HEART. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531641 OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LDA210Q/58 4822858

    Patients

    Seq Age Sex Outcome Treatment
    1