BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1739261 · Received June 29, 2010

    Report

    Report Number
    2649622-2010-06857
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    June 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION BREACHED CUT, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MEDICAL HISTORY OF HEROIN ABUSE AND CARDIAC ISSUES. SHE WAS NOTED TO HAVE DIED WITH DATE OF DEATH (B)(6) 2010. AN AUTOPSY WAS PERFORMED AND A SUPERFICIAL CONTUSION RIGHT FOREHEAD WAS REPORTED. THE ORIGIN OF THE INJURY WAS NOT REPORTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP WITH THE CORONER'S OFFICE REVEALED THE PATIENT HAD GONE THROUGH REHAB 6 MONTHS PRIOR TO HER DEATH, BUT HAD BEEN USING HEROIN FOR ABOUT A WEEK BEFORE SHE DIED. THE PATIENT WAS NOT PACEMAKER DEPENDENT, WAS NOT COMPLIANT WITH FOLLOW UP, AND HAD LAST BEEN SEEN IN THE DEVICE CLINIC/BY THE CARDIOLOGIST APPROXIMATELY ONE YEAR PREVIOUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MEDICAL HISTORY OF HEROIN ABUSE AND CARDIAC ISSUES. HE WAS NOTED TO HAVE DIED WITH DATE OF DEATH (B) (6) 2010. AN AUTOPSY WAS PERFORMED AND A SUPERFICIAL CONTUSION RIGHT FOREHEAD WAS REPORTED. THE ORIGIN OF THE INJURY WAS NOT REPORTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death COMPETITOR IMPLANTABLE DEFIB LEAD