BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1792381 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07092
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE PACING CONFIGURATION CANNOT BE RE-CONFIGURED AS IT IS A UNIPOLAR LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HIGH THRESHOLD ON THE LEFT VENTRICULAR LEAD AND AN INQUIRY AS TO IF THE PACING CONFIGURATION COULD BE CHANGED. THERE WERE NO PATIENT COMPLICATIONS OR COMPLAINTS REPORTED DUE TO THIS ISSUE AND THE LEAD REMAINS IMPLANTED AND ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD