BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 2014169 · Received March 10, 2011

    Report

    Report Number
    2647346-2011-00236
    Event Type
    Death
    Date Received
    March 10, 2011
    Date of Event
    February 4, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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) 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 ALL CONDUCTORS WERE CUT, THE OUTER INSULATION WAS BREACHED CUT, AND THERE WAS APPARENT EXPLANT DAMAGE. IT WAS FURTHER NOTED THAT VISUAL ANALYSIS ONLY WAS PERFORMED. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS ONLY 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. 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 ALL CONDUCTORS WERE CUT, THE OUTER INSULATION WAS BREACHED CUT, AND THERE WAS APPARENT EXPLANT DAMAGE. IT WAS FURTHER NOTED THAT VISUAL ANALYSIS ONLY WAS PERFORMED.(B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS ONLY WAS PERFORMED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME FOLLOWING THE PATIENTS DEATH. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death