BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 1823840 · Received September 2, 2010

    Report

    Report Number
    2647346-2010-00512
    Event Type
    Death
    Date Received
    September 2, 2010
    Date of Event
    May 23, 2010
    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
    SC, 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)(6) NO ANOMALIES FOUND. (B)(4) PROXIMAL CONDUCTOR FRACTURED, DEFIB CONDUCTOR DISTORTED, BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING OVERLAY MELTED, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD 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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. (B)(4) PROXIMAL CONDUCTOR FRACTURED, DEFIB CONDUCTOR DISTORTED, BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING OVERLAY MELTED, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PROBABLY "TWIDDLED LEADS BACK AND HAD A FALL/STROKE/SEIZURE? WITH A BACK INJURY, SO ENTIRE SYSTEM WAS REMOVED." PATIENT HAD AN MRI AND REFUSED REIMPLANT. IT WAS REPORTED THE PATIENT HAS SINCE DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PROBABLY "TWIDDLED LEADS BACK AND HAD A FALL/STROKE/SEIZURE" WITH A BACK INJURY, SO ENTIRE SYSTEM WAS REMOVED." PATIENT HAD AN MRI AND REFUSED REIMPLANT. IT WAS REPORTED THE PATIENT HAS SINCE DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REVEALED PATIENT NOT PACEMAKER DEPENDENT AND HAD A NORMAL DEVICE CHECK (B)(6)2010. LEAD INTEGRITY ALERT SOON AFTER THIS RESULTED IN DISCOVERY OF TWISTED LEADS/TWIDDLER SYNDROME ON (B)(6)2010. XRAY PERFORMED TO EXAMINE LEADS ALSO IDENTIFIED A T11 COMPRESSION FRACTURE. NEUROLOGIC REPORT ON (B)(6)2010 TO EVALUATE POSSIBLE STROKE OR SEIZURE STATED PATIENT HAD FALLEN ON FLOOR 10 DAYS PRIOR AND DIAGNOSED WITH "CONVERSION DISORDER." PATIENT HAD HISTORY OF HYPOTENSION, BUT DENIED SYNCOPE AS RECENTLY AS (B)(6)2010.

    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 73 YR Death LEAD/CCM IMPLANTABLE PACING LEAD