BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1855207 · Received October 6, 2010

    Report

    Report Number
    2649622-2010-09694
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    August 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    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. BLOOD/BODY FLUID FOUND ON ALL CONDUCTORS(NOT OBSTRUCTED). (B)(4) NO ANOMALIES FOUND; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID IN/ON HELIX/LOBE MECHANISM, OUTER TUBING OVERLAY AND DISTAL CONDUCTOR(NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WAS NOT STABLE IN THE VESSEL DURING THE ATTEMPTED IMPLANT. A SECOND LEAD WAS ATTEMPTED AND COULD NOT BE PLACED IN THE INTENDED BRANCH. A LEFT VENTRICULAR LEAD WAS NOT IMPLANTED DURING THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention