BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 DR

    MDR report key: 1961420 · Received January 14, 2011

    Report

    Report Number
    6000094-2011-00010
    Event Type
    Death
    Date Received
    January 14, 2011
    Date of Event
    March 25, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM PRIMARY CLINIC AND WILL NOT BE RECEIVED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. . EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC CUT AND THERE WAS APPARENT EXPLANT DAMAGE. VISUAL ANALYSIS PERFORMED ONLY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. VISUAL ANALYSIS PERFORMED ONLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM PRIMARY CLINIC AND WILL NOT BE RECEIVED. 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.

    Description of Event or Problem · 1

    THE DEVICE AND LEADS WERE RETURNED TO THE MANUFACTURER AFTER THE PATIENT'S DEATH WHICH WAS ONE MONTH POST IMPLANT. ADDITIONAL INFORMATION OBTAINED STATED THAT PATIENT HAD BEEN AT A CARE FACILITY, WAS DYING AND THE IMPLANTER'S OFFICE WAS QUERIED TO SEE IF THE PATIENT'S PACEMAKER COULD BE TURNED OFF. DUE TO THE PATIENT BEING PACEMAKER DEPENDENT, THE CLINIC DECLINED AND WAS SUBSEQUENTLY NOTIFIED OF PATIENT'S DEATH. NO FURTHER INFORMATION WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death