BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 2032080 · Received March 28, 2011

    Report

    Report Number
    2647346-2011-00349
    Event Type
    Death
    Date Received
    March 28, 2011
    Date of Event
    March 18, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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) NO ANOMALIES FOUND, DEFIB CONDUCTOR DISTORTED AND CUT, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER TUBING OVERLAY COSMETIC ESC, OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS BOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY - (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED WITH CAUSE OF DEATH PENDING AND UNKNOWN IF DEVICE WAS SUSPECT IN THE PATIENT'S DEATH. "STATED REMOVED LEADS AND DEVICE OK - WITH 'SOME SHOCKS'. DEVICE NOT INTERROGATED AFTER DEATH." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REPORTED THEY DID KNOW THE PATIENT HAD DIED, BUT HAD NO FURTHER INFORMATION AS TO CAUSE OF DEATH. THE PATIENT WAS PACEMAKER DEPENDENT AND HAD MEDICAL HISTORY OF SEIZURES SINCE CHILDHOOD. IT WAS LATER REPORTED THERE WAS A POTENTIAL PERFORMANCE ISSUE WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED WITH CAUSE OF DEATH PENDING AND UNKNOWN IF DEVICE WAS SUSPECT IN THE PATIENT'S DEATH. "STATED REMOVED LEADS AND DEVICE OK - WITH 'SOME SHOCKS'. DEVICE NOT INTERROGATED AFTER DEATH." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REPORTED THEY DID KNOW THE PATIENT HAD DIED, BUT HAD NO FURTHER INFORMATION AS TO CAUSE OF DEATH. THE PATIENT WAS PACEMAKER DEPENDENT AND HAD MEDICAL HISTORY OF SEIZURES SINCE CHILDHOOD.

    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 43 YR Death| O