BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2856910 · Received December 4, 2012

    Report

    Report Number
    2182208-2012-04054
    Event Type
    Death
    Date Received
    December 4, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 9, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. THE DATE OF DEATH IS UNKNOWN AT THIS TIME; THEREFORE THE DATE OF DEATH IN THE EVENT IS AN ESTIMATE. REFERENCED ARTICLE: "THE JURDHAM PROCEDURE: ENDOCARDIAL LEFT VENTRICULAR LEAD INSERTION VIA A FEMORAL TRANSSEPTAL SHEATH FOR CARDIAC RESYNCHRONIZATION THERAPY PECTORAL DEVICE IMPLANTATION." HEART RHYTHM. NOVEMBER 1 2012;9(11):1798-1804.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION ABOUT THE IMPLANTABLE CARDIAC RESYNCHRONIZATION (CRT)SYSTEM. THE PATIENT EXPIRED ONE MONTH AFTER LEAD IMPLANT DUE TO SEPTICEMIA AS A RESULT OF POCKET INFECTION. OF NOTE, THIS PATIENT HAD "NUMEROUS" POCKET MANIPULATIONS BEFORE FINALLY HAVING LEFT VENTRICULAR (LV) LEAD PLACEMENT. AFTER THE LV LEAD PLACEMENT, THE PATIENT HAD BEEN DISCHARGED AND HAD AN IMPROVEMENT IN THE NEW YORK HEART ASSOCIATION'S FUNCTIONAL CLASS (HEART FUNCTION) PRIOR TO THE INFECTION. THERE WAS NO LEAD-DEATH RELATEDNESS INDICATED. FURTHER FOLLOW UP DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death