BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1863402 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11323
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. FULL LEAD WAS RETURNED AND ANALYZED. DISTAL CONDUCTOR HAD BLOOD/BODY FLUID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE LEAD COULD NOT GET INTO THE VEIN. A DIFFERENT LEAD WAS SUCCESSFULLY IMPLANTED. 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 77 YR Required Intervention