BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2203339 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12325
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WHO HAS A BI-VENTRICULAR DEFIBRILLATION SYSTEM, HAD A LEFT VENTRICULAR LEAD SHOWING INTERMITTENT CAPTURE ALONG WITH DIAPHRAGMATIC STIMULATION. THE LEAD REMAINED IN USE. THE PATIENT WAS TO HAVE A SECOND ATTEMPT TO PLACE A NEW LEFT VENTRICULAR LEAD WITH AN IMPLANT FOR THE ATTAIN SUCCESS STUDY; TWO ATTEMPTS WERE MADE TO PLACE THE LEAD. THE PHYSICIAN WAS UNABLE TO OBTAIN ADEQUATE DISTAL LOCATIONS. THE LEAD WAS NOT USED, AND NO OTHER LEAD IMPLANTED AT THAT TIME. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM A FEW MONTHS LATER AND TWO EPI-CARDIAL LEADS WERE PLACED. THE ORIGINAL LEFT VENTRICULAR LEAD WITH THE INTERMITTENT CAPTURE WAS CAPPED AT THAT TIME. 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 STARFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4195 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIBRILLATOR| 4076 IMPLANTABLE PACING LEAD