BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREEPI

    MDR report key: 2810157 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03663
    Event Type
    Death
    Date Received
    October 31, 2012
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # PRODUCT ID# 4965 A PROXIMAL PORTION WAS RECEIVED MEASURING 11 CM. A DISTAL PORTION WAS RECEIVED MEASURING 3 CM. THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO A CUT, THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO, VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED,

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONALLY NOTED WAS THE PHYSICIAN "WANTED TO PUT IN A SECOND VENTRICULAR LEAD" AS THE PATIENT WAS "COMPLETELY PACEMAKER DEPENDENT," THIS WAS "HIGHLY RESIST[ED]." THE PHYSICIAN FURTHER STATED, THIS WAS "NOT AN ISSUE WITH THE PRODUCT." THE CAUSE OF DEATH WAS REQUESTED AND WILL NOT BE RECEIVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED VIA A LEGAL FORM THAT THE RIGHT ATRIAL (RA) LEAD WAS FRACTURED. THE CAUSE OF DEATH WAS ALSO REPORTED POST AUTOPSY AS CARDIAC DEATH DUE TO LEAD FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED. ONE WEEK PRIOR TO THE PATIENT'S DEATH, A LEAD WARNING WAS EXPERIENCED BY THE RIGHT VENTRICULAR (RV) LEAD. ON THE DAY OF DEATH, THE PATIENT WAS "PLAYING OUTSIDE AND COLLAPSED," THEN AIRLIFTED TO THE HOSPITAL. THE DEVICE WAS INTERROGATED AND A "STEADY RISE IN RV IMPEDANCE INDICATING A FRACTURE OCCURRING" WAS NOTED. FURTHER REPORTED WAS THE PATIENT HAD BEEN "DOWN ABOUT AN HOUR PRIOR TO THE TEAM WORKING ON [THE PATIENT]." THE PATIENT WAS PRONOUNCED DEAD FOUR HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death (B)(4) IMPLANTABLE PULSE GENERATOR