BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1991556 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02435
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    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 THE LEFT VENTRICULAR LEAD HAD POSSIBLE FRACTURE, HIGH IMPEDANCE, AND LOSS OF CAPTURE. IT WAS ALSO REPORTED THAT THE PATIENT WENT TO THE HOSPITAL FOR DECOMPENSATED HEART FAILURE (HF). THE LEAD THRESHOLD WAS REPROGRAMMED, AND THE LEAD POLARITY WILL BE PROGRAMMED TO UNIPOLAR. THE LEAD REMAINS 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 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD