BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN COMMAND

    MDR report key: 2203819 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11742
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    April 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DQY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THESE MODEL NUMBERS ARE NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE OF THE ATTAIN SUCCESS STUDY, THE PATIENT HAD SIGNIFICANT FIBROUS TISSUE IN THE SUBCLAVIAN VESSEL AND SUPERIOR VENA CAVA (SVC) DUE TO PRIOR LEADS. TWO GUIDE CATHETERS WERE ATTEMPTED BUT WOULD NOT ADVANCE. VENOGRAPHY SHOWED THAT THE GUIDE CATHETERS HAD GONE INTO A FALSE CHANNEL AND CAUSED A PROBABLE DISSECTION OF THE SVC AND POSSIBLY INTO THE PLEURAL SPACE. THE SECOND GUIDE CATHETER WAS PULLED BACK AND SUCCESSFULLY MADE IT THROUGH THE SVC. THE PATIENT WAS TYPED AND CROSSED FOR FOUR UNITS OF BLOOD IN CASE THERE WAS A NEED TRANSFUSE AND AN ARTERIAL LINE WAS PLACED. A CHEST X-RAY SHOWED NO EVIDENCE OF PNEUMOTHORAX OR CARDIAC PERFORATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN COMMAND LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC PUERTO RICO, INC. 6250EH ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 6940 IMPLANTABLE PACING LEAD| 6942 IMPLANTABLE TACHY LEAD