BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 3992050 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10066
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: MODEL: 5076-45, LEAD; IMPLANT: (B)(6) 2010. MODEL: 5076-52, LEAD; IMPLANT: (B)(6) 2010. MODEL: 6935M55, LEAD, IMPLANT: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PHRENIC NERVE STIMULATION (PNS) WAS EVIDENT ON THE PATIENTS LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REPLACED. THE PNS REMAINS EVIDENT ON THE NEWLY PLACED LV LEAD. THE 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
    470183 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R DTBA1D4, ICD