BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1864945 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10887
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE ATRIAL LEAD AT DEVICE CHANGEOUT. THE PHYSICIAN NOTICED T-WAVE OVERSENSING ON THE ANALYZER AND DURING FLUOROSCOPY THE LEAD LOOKED TO HAVE "FLOPPED DOWN TOWARDS THE VALVE". THE LEAD WAS REPORTED AS HAVING BEEN REPLACED BY A NEW LEAD. 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. 4058M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention UNKNOWN IMPLANTABLE PULSE GENERATOR| 4024 IMPLANTABLE PACING LEAD