BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3210510 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03338
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 12, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORATION WAS INITIALLY REPORTED AS OCCURRING WITH TWO LEADS BUT LATER WAS REPORTED AS OCCURRING ON ONLY ONE LEAD. THE LEAD INVOLVED IN THE EVENT, MODEL 7122Q/58, SN (B)(4) WAS REPORTED UNDER MDR NUMBER 2938836-2013-03836. LEAD MODEL 7122Q/58, SN (B)(4) WAS THE REPLACEMENT LEAD AND REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE LEAD IMPLANT, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION DUE TO PERFORATION. PERICARDIOCENTESIS RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310943 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention