BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 3160313 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07946
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    August 11, 2012
    Report Date
    March 15, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED; THE TIP SEAL ON THE DISTAL ELECTRODE OF THE LEAD SHOWED EVIDENCE OF BLOOD INGRESSION, AND THE OVERLAY TUBING OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION.

    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

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS ATTEMPTED AT IMPLANT BUT WAS UNSUITABLE DUE TO PATIENT ANATOMY. THE LEAD WAS ALSO PAST ITS USE-BY -DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259754 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1