BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL MRI

    MDR report key: 6567064 · Received May 15, 2017

    Report

    Report Number
    2017865-2017-03526
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    April 20, 2017
    Report Date
    September 28, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    DXY
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA/510K # SHOULD HAVE BEEN P140033 RATHER THAN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH FEVER AND POCKET SWELLING. THE PATIENT HAD DEVELOPED A POCKET INFECTION. THERE WERE NO ADVERSE CONSEQUENCES DUE TO THE EXPLANT. THE PATIENT'S CONDITION WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347665 TENDRIL MRI PERMANENT PACEMAKER ELECTRODE DXY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LPA1200M/52 S000023313

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)| (B)(4)