BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1926231 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14244
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 30, 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
    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 FOR ANALYSIS. FURTHER TESTING REVEALED DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND. FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL IMPLANT, A STABLE LEFT VENTRICULAR LEAD POSITION COULD NOT BE OBTAINED DUE TO PATIENT ANATOMY FOR AN INITIAL LEAD. THIS LEAD WAS REMOVED AND ANOTHER LEAD WAS ATTEMPTED TO BE IMPLANTED. A STABLE LEAD POSITION COULD NOT BE OBTAINED DUE TO PATIENT ANATOMY FOR THIS SECOND LEAD, AND THE LEAD WAS REMOVED. PER THE MANUFACTURER'S DEVICE IMPLANT DATABASE, THE PATIENT WAS SUBSEQUENTLY IMPLANTED WITH A DUAL CHAMBER DEFIBRILLATOR. 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 ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other