BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 3160331 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07939
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: OCCURRENCE OF PHRENIC NERVE STIMULATION IN CARDIAC RESYNCHRONIZATION THERAPY PATIENTS: THE ROLE OF LEFT VENTRICULAR LEAD TYPE AND PLACEMENT SITE. EUROPACE: EUROPEAN PACING, ARRHYTHMIAS, AND CARDIAC ELECTROPHYSIOLOGY: JOURNAL OF THE WORKING GROUPS ON CARDIAC PACING, ARRHYTHMIAS, AND CARDIAC CELLULAR ELECTROPHYSIOLOGY OF THE EUROPEAN SOCIETY OF CARDIOLOGY. 2013;15(1):77-82. PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS A COSMETIC DEPRESSION ON THE OUTER INSULATION. CONCOMITANT PRODUCTS: 6949, IMPLANTABLE TACHY LEAD, (B)(6) 2007; C154DWK, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), (B)(6) 2007; 4076, IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS A COSMETIC DEPRESSION ON THE OUTER INSULATION. PRODUCT ID 6949, IMPLANTABLE TACHY LEAD IMPLANTED: 2007-(B)(6), PRODUCT ID C154DWK, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: 2007-(B)(6), PRODUCT ID 4076 IMPLANTABLE PACING LEAD, IMPLANTED: 2007-(B)(6).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. THE PATIENT EXPERIENCED DIAPHRAGMATIC MUSCLE STIMULATION. THE LEFT VENTRICULAR (LV) OUTPUT WAS ADJUSTED TO RESOLVE THE ISSUE AND THE LEAD REMAINED IN USE AT THAT TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. THE PATIENT EXPERIENCED DIAPHRAGMATIC MUSCLE STIMULATION. THE LEFT VENTRICULAR (LV) OUTPUT WAS ADJUSTED TO RESOLVE THE ISSUE AND THE LEAD REMAINED IN USE AT THAT TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260991 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R