BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2941468 · Received February 4, 2013

    Report

    Report Number
    2182208-2013-00015
    Event Type
    Death
    Date Received
    February 4, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 11, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THERE IS NO INFORMATION GIVEN AS TO THE DATE OF DEATHS FOR ANY OF THE PATIENTS; THEREFORE, THE DATE OF DEATH INCLUDED IN THIS REPORT IS PURELY AN ESTIMATE. REFERENCED ARTICLE: "SPRINT FIDELIS LEAD FRACTURES IN PATIENTS WITH CARDIAC RESYNCHRONIZATION THERAPY DEVICES: INSIGHT FROM THE (B)(4) STUDY." CIRCULATION. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD MODEL. 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: FRACTURE, INFECTION, INAPPROPRIATE SHOCKS, OVERSENSING, IMPEDANCE RISE, DISLODGEMENT, AND REVISION FOR OTHER NON-SPECIFIED REASONS. THERE ARE PATIENT DEATHS REFERENCED IN THE ARTICLE; HOWEVER, THE ARTICLE DID NOT INFER OR INDICATE THAT ANY OF THE DEATHS WERE LEAD-RELATED. THE CAUSE OF THE DEATHS IS UNKNOWN. THE STATUS OF THE LEADS IS UNKNOWN, ALTHOUGH MANY WERE SAID TO BE REVISED. 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
    45947 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R