BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 2811480 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17111
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE DEVICE WAS NEARING RECOMMENDED REPLACEMENT TIME BATTERY VOLTAGE SOONER THAN EXPECTED. IT WAS ALSO INDICATED THE LEFT VENTRICULAR (LV) OUTPUTS WERE HIGH WITH LOWER IMPEDANCE. THE DEVICE AND LV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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 54 YR Other 4076-1 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4076-2 IMPLANTABLE PACING LEAD