BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX OTW

    MDR report key: 3050956 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04792
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF FEELING 'MUSCLE CONTRACTIONS' AND 'HEART FLUTTERING,' WHICH ESPECIALLY OCCURED WHEN THE PATIENT WAS BENT OVER ON THE SIDE. THE LEAD WAS REPROGRAMMED TWICE, AND WAS EVENTUALLY REPOSITIONED. THE PATIENT'S SYMPTOMS APPEAR TO HAVE RESOLVED FOLLOWING THE REPOSITIONING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149769 ATTAIN STARFIX OTW DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R D314TRG IMPLANTABLE DEFIBRILLATOR