BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952045 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00116
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: "THE IMPACT OF LEFT VENTRICULAR LEAD POSITION ON LEFT VENTRICULAR REVERSE REMODELLING AND IMPROVEMENT IN MECHANICAL DYSSYNCHRONY IN CARDIAC RESYNCHRONIZATION THERAPY." EUR. HEART J. CARDIOVASC. IMAGING. (B)(6) 2012;13(12):991-1000.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: DISLODGEMENT, PHRENIC NERVE STIMULATION, "INSTABILITY," AND "INSUFFICIENT PACING CAPTURE." THE DISLODGED LEADS WERE "SUCCESSFULLY" REPOSITIONED. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55868 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R