BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 3925910 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15695
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    December 22, 2010
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED AN ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403522 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1999/40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention