BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1862886 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10488
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COMPLAINED OF A "THUMPING SENSATION ON LEFT SIDE OF CHEST, SOMETIMES TWICE A DAY, DIZZINESS EPISODES WHILE ON RIDE-ON MOWER AND EATING, AND FEELING TIRED." DEVICE INTERROGATION REVEALED "LV LEAD DYSFUNCTION." THE DEVICE WAS REPROGRAMMED TO DDI RATE 40, RV PACING ONLY. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 Required Intervention