BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1874514 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11433
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. BLOOD WAS NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED); FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT TO IMPLANT THE LEFT VENTRICULAR (LV) LEAD, THE LEAD DISLODGED WHEN THE INTRODUCER SHEATH WAS BEING SLIT. THE LEAD WAS REMOVED. THE PHYSICIAN WILL CONSIDER ATTEMPTING A NEW LV LEAD AT A LATER DATE. 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 ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention