BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1913384 · Received December 3, 2010

    Report

    Report Number
    2649622-2010-12200
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    July 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. VISUAL ANALYSIS PERFORMED ONLY.

    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) NO ANOMALIES WERE FOUND. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED TWELVE DAYS AFTER THE DEVICE REPLACEMENT PROCEDURE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED TWELVE DAYS AFTER THE DEVICE REPLACEMENT PROCEDURE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED, DURING THE DEVICE UPGRADE PROCEDURE, THE PHYSICIAN NOTED THERE WAS A CUT IN THE EXISTING RIGHT VENTRICULAR LEAD INSULATION IN WHICH THE PHYSICIAN REPAIRED. THE RIGHT VENTRICULAR LEAD REMAINED IN USE AND WAS CONNECTED TO THE NEW DEVICE. THE PATIENT WAS DISCHARGED AND TRANSFERRED TO A NURSING HOME FOR CARE. THE NURSE ALSO REPORTED THE PATIENT HAD MULTIPLE ADMISSIONS TO THE HOSPITAL FOR CONGESTIVE HEART FAILURE AND FLUID OVERLOAD. THE NURSE INDICATED THE PATIENT HAD END-STAGE RENAL DISEASE. THE CAUSE OF DEATH ISN'T KNOWN AND IS BEING REQUESTED FROM THE NURSING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death