BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX OTW

    MDR report key: 3152435 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06804
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    December 27, 2012
    Report Date
    April 11, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: 6947M62, IMPLANTABLE TACHY LEAD, (B)(6) 2012; 6725, IMPLANTABLE ADAPTOR, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "BUMPING" IN THEIR CHEST WALL WHILE LYING ON THEIR LEFT SIDE. THE LEFT VENTRICULAR LEAD WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. IT WAS NOTED THAT THE PATIENT WAS ENROLLED IN (B)(4). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253110 ATTAIN STARFIX OTW DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419578

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention D314TRM BI-VENTRICULAR DEFIBRILLATOR