BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1813581 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08892
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    May 26, 2009
    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
    ND, 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) FULL LEAD WAS RETURNED AND ANALYZED. VISUAL ANALYSIS NOTED THE RETURNED DEVICE WITH TWO SETS OF SETSCREW MARKS ON THE IS-1 PIN. ONE SET OF SETSCREW MARKS ON THE IS-1 PIN IS TOO PROXIMAL, THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE. PRIMARY ANALYSIS FINDINGS: NO ANOMALIES FOUND. PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED) VARIOUS/THROUGHOUT. OUTER INSULATION BREACHED/CUT AT GENERATOR END (WITHIN 20CM PROXIMAL END). BLOOD IN/ON HELIX/LOBE MECHANISM. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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) FULL LEAD WAS RETURNED AND ANALYZED. VISUAL ANALYSIS NOTED THE RETURNED DEVICE WITH TWO SETS OF SETSCREW MARKS ON THE IS-1 PIN. ONE SET OF SETSCREW MARKS ON THE IS-1 PIN IS TOO PROXIMAL, THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE. PRIMARY ANALYSIS FINDINGS: NO ANOMALIES FOUND. PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED) VARIOUS/THROUGHOUT. OUTER INSULATION BREACHED/CUT AT GENERATOR END (WITHIN 20CM PROXIMAL END). BLOOD IN/ON HELIX/LOBE MECHANISM. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD IMPEDANCE ALERT TRIGGERED. ATRIAL IMPEDANCE VIA THE ANALYZER WAS >4000 OHMS. APPARENT CONDUCTOR FRACTURE ALSO REPORTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD IMPEDANCE ALERT TRIGGERED. ATRIAL IMPEDANCE VIA THE ANALYZER WAS >4000 OHMS. APPARENT CONDUCTOR FRACTURE ALSO REPORTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVELED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP WITH THE CLINIC REVEALED PATIENT HAD BEEN RELEASED TO HOSPICE CARE (B)(6) 2009 AND LAST SEEN IN CLINIC (B)(6) 2009 WITH "NOTHING UNUSUAL NOTED." THE PATIENT WAS NOT PACEMAKER DEPENDENT. CAUSE OF DEATH WAS UNKNOWN, "ASSUMPTION OF CARDIOMYOPATHY AND CHF" AND NO AUTOPSY WAS PERFORMED.

    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 70 YR Death| R 0158 COMPETITOR IMPLANTABLE TACHY LEAD