BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3924115 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15048
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUOROSCOPY REVEALED THAT THE ATRIAL LEAD HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE PATIENT WAS IN GOOD CONDITION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT ON (B)(6) 2014 A FLUOROSCOPY REVEALED THAT THE ATRIAL LEAD HAD DISLODGED AGAIN. THE LEAD WAS SUCCESSFULLY REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399801 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7172Q/58, (B)(4)