BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1925798 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14063
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 8, 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
    OH, 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 WERE FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN WAS UNABLE TO FIND A GOOD PLACEMENT FOR CAPTURE FOR THE 4196 LEAD. THE PHYSICIAN THEN ATTEMPTED A 4194 LEAD DUE TO RING SIZE FOR PLACEMENT WITHOUT SUCCESS. THE 4196 LEAD WAS ATTEMPTED AGAIN, THIS TIME SUCCESSFULLY DUE TO A SMALLER VESSEL. THE 4194 LEAD WAS REMOVED, AND THE 4196 LEAD IS STILL IN USE. 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 87 YR Other