BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2123470 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07969
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    December 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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) THE FULL LEAD WAS RETURNED AND NO ANOMALIES FOUND. (B)(4) THE FULL LEAD WAS RETURNED, AND NO ANOMALIES FOUND, ALL CONDUCTORS BLOOD, BODY FLUID (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS COULD NOT BE PLACED DURING THE IMPLANT PROCEDURE. 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 62 YR Other