BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LV LEAD

    MDR report key: 3153050 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05787
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    May 19, 2009
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND NO ANOMALIES. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. 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. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. THE PATIENT EXPERIENCED DIAPHRAGMATIC MUSCLE STIMULATION ONE DAY POST IMPLANT. THE PHYSICIAN WAS UNABLE TO REPROGRAM TO AVOID THE STIMULATION; THEREFORE, THE LEAD WAS THEN REPLACED AND RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254846 LV LEAD DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4396

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R