BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 3993161 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09453
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. CONCOMITANT MEDICAL PRODUCTS: ADDR01 IPG, IMPLANTED: (B)(6) 2008; 5092-58 LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. ANALYSIS COMMENTS NOTED THAT THE ELECTRICAL RESISTANCE AND CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE TWO DIFFERENT LEFT VENTRICULAR (LV) LEADS WERE ATTEMPTED BUT WERE NOT IMPLANTED. THE FEW BRANCHES THAT THE LV LEADS WERE ABLE TO BE DELIVERED TO HAD HIGH OUTPUTS CAPTURING ONLY AT TEN VOLTS OR DIAPHRAGMATIC STIMULATION OR WERE UNSTABLE. THEREFORE, NO LV LEADS WERE IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467241 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR 5592-45 LEAD