BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2071166 · Received April 27, 2011

    Report

    Report Number
    2649622-2011-07332
    Event Type
    Death
    Date Received
    April 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY - (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE OUTER INSULATION HAD A COSMETIC CUT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY - (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE OUTER INSULATION HAD A COSMETIC CUT. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FRACTURED. THE LEAD INTEGRITY ALERT WAS LOADED AND THERE WERE FOUR INAPPROPRIATE SHOCKS. THE LEAD WAS NOT GOING TO BE REPLACED AS THE PATIENT WAS ON HOSPICE. IT WAS REPORTED THE PATIENT HAD DIED WITH CAUSE OF DEATH REPORTED TO BE HYPERTENSION, DIABETES, AND CONGESTIVE HEART FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FRACTURED. THE LEAD INTEGRITY ALERT WAS LOADED AND THERE WERE FOUR INAPPROPRIATE SHOCKS. THE LEAD WAS NOT GOING TO BE REPLACED AS THE PATIENT WAS ON HOSPICE. IT WAS REPORTED THE PATIENT HAD DIED WITH CAUSE OF DEATH REPORTED TO BE HYPERTENSION, DIABETES, AND CONGESTIVE HEART FAILURE. FOLLOW UP WITH THE CLINIC REPORTED THE HIGH POWER LEAD HAD BEEN DEACTIVATED TWO MONTHS PRIOR TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5594 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| O