BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL MRI

    MDR report key: 7158265 · Received January 2, 2018

    Report

    Report Number
    2938836-2018-00028
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 13, 2017
    Report Date
    February 26, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    DXY
    PMA / PMN Number
    P140033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Additional Manufacturer Narrative · 1

    CORRECTION: SERIAL NUMBER OF THE PRODUCT SHOULD HAVE BEEN (B)(4) RATHER THAN (B)(4). MODEL NUMBER: LPA1200M/52, SERIAL NUMBER: (B)(4), LOT NUMBER: 6090681, DEVICE MANUFACTURE DATE: APR 14, 2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, STYLET COULD NOT BE INSERTED INTO THE LEAD. LEAD MALFUNCTION WAS SUSPECTED. LEAD WAS NOT USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LEAD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89 TENDRIL MRI PERMANENT PACEMAKER ELECTRODE DXY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LPA1200M/52 6090681

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR