BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2812668 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15952
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CODED FOLLOWING AN ABLATION PROCEDURE. THE PATIENT WAS FOUND TO BE HYPOXIC AND HYPERKALEMIC. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NOT CAPTURING. IT WAS ALSO NOTED THAT THE DEVICE WAS OVERSENSING NOISE DURING AN IMPEDANCE TEST. THE DAY FOLLOWING THE PROCEDURE THE DEVICE WAS CHECKED AGAIN AND THE LV LEAD WAS FOUND TO BE FUNCTIONING APPROPRIATELY. THE PHYSICIAN BELIEVES THE LACK OF CAPTURE WAS DUE TO THE PATIENT'S CLINICAL STATE. THE LEAD AND DEVICE REMAIN IN USE. NO FURTHER 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. 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD