BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 3992222 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09996
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 10, 2014
    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
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT CONTINUED TO EXPERIENCE DIAPHRAGMATIC STIMULATION. DURING THE REVISION IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD MIGRATED DUE TO PATIENT ANATOMY. THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HICCUPPING SENSATION. EXTRA CARDIAC STIMULATION WAS ALSO REPORTED. NO INTERVENTION WAS DONE. IT WAS NOTED THAT PATIENT WAS PART OF THE PRODUCT SURVEILLANCE REGISTRY STUDY. THE LEFT VENTRICULAR (LV) LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING A HICCUPPING SENSATION. REPROGRAMMING WAS DONE AND THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. IT WAS NOTED THAT PATIENT WAS PART OF THE PRODUCT SURVEILLANCE REGISTRY STUDY. THE PATIENT WILL FOLLOW-UP IN ONE MONTH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470937 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R D224DRG ICD