BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1854950 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09199
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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. LEAD IS STRETCHED; DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO IMPLANT THE LEFT VENTRICAL (LV) LEAD. THERE WERE HIGH PACING THRESHOLDS ATTRIBUTED TO PATIENT ANATOMY AND WERE UNACCEPTABLE TO THE PHYSICIAN. THE LEAD WAS REMOVED AND A DIFFERENT MODEL LV LEAD WAS SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS 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