BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1791708 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06966
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    October 19, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    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: (B)(4) NO ANOMALIES FOUND; THE DISTAL CONDUCTOR WAS DISTORTED, THE HELIX WAS STRETCHED OUT OF SPECIFICATION, THE HELIX WAS FULLY EXTENDED, BLOOD/TISSUE WAS PRESENT IN/ON THE HELIX MECHANISM/SLEEVE HEAD AND THE LEAD EXHIBITED APPARENT DAMAGE AT IMPLANT. THE FULL LEAD WAS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND; THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID PRESENT (NOT OBSTRUCTED). THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE IMPLANT PROCEDURE THAT THE 6947 WAS ATTEMPTED BUT NOT USED DUE TO UNUSUAL ELECTRICAL CHARACTERISTICS SUCH AS INTERMITTENT CAPTURE, EGM PROBLEMS AND NON-OPERATIONAL HELIX. THE LEAD WAS NOT IMPLANTED. IMPLANTATION OF A LEFT VENTRICULAR LEAD (4196) WAS ATTEMPTED, BUT NOT USED. 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 84 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB