BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 3861808 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07171
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 507652 LEAD, IMPLANTED: (B)(6) 2014; C2TR01 CRT-P, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN NOTED THAT THE PATIENT'S ANATOMY WAS DIFFICULT TO MANEUVER. THE LEFT VENTRICULAR (LV) LEAD WAS SUCCESSFULLY PLACED, HOWEVER THAT NIGHT, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION THAT WAS UNABLE TO BE PROGRAMMED AROUND. THE LV LEAD WAS TEMPORARILY TURNED OFF UNTIL THE NEXT AFTERNOON, WHEN A STARFIX LV LEAD WAS ATTEMPTED. THE PHYSICIAN WAS UNSUCCESSFUL IN PLACED THE NEW LV LEAD IN A SUITABLE LOCATION. THE PHYSICIAN OPTED TO IMPLANT THE ORIGINAL LV LEAD AGAIN IN AN ANTERIOR BRANCH WHICH WAS THE ONLY LOCATION SUITABLE FOR ACCEPTABLE THRESHOLDS WITHOUT DIAPHRAGMATIC STIMULATION. THE LV LEAD REMAINS 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
    341471 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR 507645 LEAD