BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151651 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01308
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWP
    PMA / PMN Number
    P010015
    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. 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 ON TWO SEPARATE OCCASIONS; ONE DAY AND FOUR DAYS POST IMPLANT. THE LEFT VENTRICULAR (LV) OUTPUT WAS ADJUSTED BOTH TIMES AND THE LEAD REMAINED IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253156 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 419378C

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R