BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2073323 · Received May 1, 2011

    Report

    Report Number
    2649622-2011-07373
    Event Type
    Death
    Date Received
    May 1, 2011
    Date of Event
    March 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. EVALUATION SUMMARY - (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. 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. EVALUATION SUMMARY - (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    REVIEW OF MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY EIGHT MONTHS AFTER DEVICE SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE NURSE AT THE CLINIC REPORTED THEIR RECORDS INDICATE THE PATIENT EXPERIENCED A FALL TWO DAYS PRIOR TO DEATH AND SUFFERED A SUBDURAL HEMATOMA THAT WAS INOPERABLE. THE EXACT CAUSE OF DEATH IS NOT IN THEIR RECORDS. THERE IS NO ALLEGATION OF A DEVICE OR LEAD ISSUE AS RELATED TO THE DEATH. PATIENT'S PACEMAKER DEPENDENCY NOT KNOWN TO NURSE.

    Description of Event or Problem · 1

    REVIEW OF MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY EIGHT MONTHS AFTER DEVICE SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 78 YR Death