BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6661861 · Received June 22, 2017

    Report

    Report Number
    8030904-2017-00002
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    June 14, 2017
    Report Date
    July 25, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    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

    NO COMPLAINT WAS RECEIVED WITH THE RETURN OF THE DEVICE; FAILURE EVENT OBSERVED DURING ANALYSIS. A PARTIAL LEAD WAS RETURNED FOR ANALYSIS IN 2 SEGMENTS. THE CONNECTOR PORTION MEASURING 6.9 CM AND THE DISTAL PORTION MEASURING 49.2 CM. EXTERNAL INSULATION ABRASION WAS NOTED AT 45.4-45.7 CM FROM THE DISTAL TIP CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE SILICONE COATING BENEATH WAS INTACT AT THIS LOCATION. ALL OTHER DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT REQUIRED TO CHANGE TO 2017865 WHICH WAS EARLIER REPORTED AS 8030904. AN UPDATED MFR REPORT NUMBER 3 CAN NOT BE PROVIDED, AS THIS NUMBER IS SYSTEM AUTOMATED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO ADD EVENT DATE, WHICH WAS NOT REPORTED EARLIER.

    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
    442886 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7120Q/58 3082539

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR