BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 1911829 · Received December 1, 2010

    Report

    Report Number
    2647346-2010-00760
    Event Type
    Death
    Date Received
    December 1, 2010
    Date of Event
    May 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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) NO ANOMALIES FOUND. (B)(4), PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. DISTAL CONDUCTOR CUT, OUTER INSULATION BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY. ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC CUT AND DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY.

    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) NO ANOMALIES FOUND. (B)(4), PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. DISTAL CONDUCTOR CUT, OUTER INSULATION BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4), PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC CUT AND DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SIX MONTHS AFTER DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS FURTHER REPORTED BY THE PHYSICIAN'S NURSE THAT THE CIRCUMSTANCES OF THE PATIENT'S DEATH ARE UNKNOWN. THE PATIENT'S WAS AT THE (B)(6) HOSPITAL FOR APPROXIMATELY SIX MONTHS PRIOR TO THE PATIENT'S DEATH. THE CAUSE OF DEATH AND DEVICE RELATEDNESS IS UNKNOWN. THE PATIENT HAD EXTENSIVE CARDIAC HISTORY AND THE PATIENT'S SON STATED THE DEATH WAS DUE TO CORONARY DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SIX MONTHS AFTER DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 77 YR Death