BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISENSE

    MDR report key: 4202030 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04877
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    May 16, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVAL DESCRIPTION: THE REPORTED FIELD EVENT OF HELIX ANOMALY WAS NOT CONFIRMED. HELIX MECHANISM WAS FOUND TO BE NORMAL. FOREIGN MATERIAL WAS FOUND ON THE HELIX WHICH COULD HAVE PREVENTED THE HELIX EXTENSION. THE FOREIGN MATERIAL WAS BELIEVED TO BE RESIDUES FROM DEXAMETHASONE SODIUM AND SILICON ADHESIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX WOULD NOT EXTEND. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34175 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1999/52

    Patients

    Seq Age Sex Outcome Treatment
    1