BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 2983869 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01546
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 25, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC NOT FEELING WELL. AN ECHOCARDIOGRAM REVEALED PERICARDIAL EFFUSION. THE PATIENT WAS ADMITTED TO THE HOSPITAL. A CT SCAN REVEALED THE RIGHT ATRIAL LEAD HAD PERFORATED THE PATIENT. THE LEAD WAS EXPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88361 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1999/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention