BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELECTSITE DEFLECTABLE CATH

    MDR report key: 2060294 · Received April 15, 2011

    Report

    Report Number
    2182208-2011-00639
    Event Type
    Death
    Date Received
    April 15, 2011
    Date of Event
    March 1, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K033989
    Removal / Correction Number
    ASKU
    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: "SAFETY AND PERFORMANCE OF A SYSTEM SPECIFICALLY DESIGNED FOR SELECTIVE SITE PACING." PACING AND CLINICAL ELECTROPHYSIOLOGY - PACE. 2011;34(3):339-347.

    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. 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: "SAFETY AND PERFORMANCE OF A SYSTEM SPECIFICALLY DESIGNED FOR SELECTIVE SITE PACING." PACING AND CLINICAL ELECTROPHYSIOLOGY - PACE. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS SYSTEM. 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: LEAD DISLODGEMENT, PERFORATION, IMPLANT FAILURES, TWIDDLER'S SYNDROME, DECREASE IN PACING IMPEDANCE, AND UNACCEPTABLE THRESHOLDS. THERE WERE ALSO 22 DEATHS REPORTED DUE TO NON-CARDIAC, SUDDEN CARDIAC AND NON-SUDDEN CARDIAC ISSUES. THERE IS NO ALLEGATION THAT THE DEATHS WERE DEVICE-RELATED. ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW UP INDICATED THAT THIS LEAD HAD INCREASED THRESHOLDS AND LOW SENSING. THE LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS SYSTEM. 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: LEAD DISLODGEMENT, PERFORATION, IMPLANT FAILURES, TWIDDLER'S SYNDROME, DECREASE IN PACING IMPEDANCE, AND UNACCEPTABLE THRESHOLDS. THERE WERE ALSO 22 DEATHS REPORTED DUE TO NON-CARDIAC, SUDDEN CARDIAC AND NON-SUDDEN CARDIAC ISSUES. THERE IS NO ALLEGATION THAT THE DEATHS WERE DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTSITE DEFLECTABLE CATH LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC, INC. C304L69 ASKU

    Patients

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