BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1883723 · Received October 27, 2010

    Report

    Report Number
    2649622-2010-11977
    Event Type
    Death
    Date Received
    October 27, 2010
    Date of Event
    January 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. EVALUATION SUMMARY - (B)(4) NO ANOMALIES FOUND; BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM. THE FULL LEAD WAS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND; ALL CONDUCTORS WERE DISTORTED, THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID PRESENT, THE OUTER INSULATION WAS BREACHED/CUT, BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM, THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL, AND THE LEAD EXHIBITED APPARENT IMPLANT DAMAGE. THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT A VENTRICULAR LEAD IMPLANTATION WAS ATTEMPTED, BUT THE LEAD WAS NOT USED DUE TO POSITIONING/FIXATION DIFFICULTY. THE LEAD WAS EXPLANTED AND A SECOND VENTRICULAR DEFIBRILLATOR LEAD WAS SUCCESSFULLY IMPLANTED. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 78 DAYS LATER. FOLLOW UP REVEALED PATIENT CAME IN WITH CHOLECYSTITIS, HAD A LAPAROSCOPY AND ARRESTED POST SURGERY. THE PATIENT WAS REINTUBATED, DEFIBRILLATED, AND RESUSCITATED BUT SUFFERED A SIGNIFICANT ANOXIC BRAIN INJURY. THE HEALTH CARE PROFESSIONAL STATED PATIENT DEATH WAS NOT DEVICE SYSTEM RELATED. FAMILY ELECTED HOSPICE CARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT A VENTRICULAR LEAD IMPLANTATION WAS ATTEMPTED, BUT THE LEAD WAS NOT USED DUE TO POSITIONING/FIXATION DIFFICULTY. THE LEAD WAS EXPLANTED AND A SECOND VENTRICULAR DEFIBRILLATOR LEAD WAS SUCCESSFULLY IMPLANTED. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 78 DAYS LATER. 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD