BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2791497 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14532
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO POSITION THE RIGHT VENTRICULAR EPICARDIAL LEAD DUE TO THE ADIPOSE TISSUE COVERING THE PATIENT'S HEART. ONE DAY AFTER THE LEAD IMPLANT THE LEAD WAS NOT CAPTURING. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR