BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2051428 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05562
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 11, 2011
    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
    TN, 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 FOR (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN WAS UNABLE TO PLACE TWO LEADS DUE TO DIFFICULT PATIENT ANATOMY AND DIAPHRAGMATIC STIMULATION. NEITHER LEAD WAS USED, AND ANOTHER LEAD WAS 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 76 YR Other 4076 IMPLANTABLE PACING LEAD