BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO DR

    MDR report key: 1882269 · Received October 26, 2010

    Report

    Report Number
    2647346-2010-00695
    Event Type
    Death
    Date Received
    October 26, 2010
    Date of Event
    November 4, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 RETURNED AND ANALYZED. NO ANOMALIES FOUND, DISTAL CONDUCTOR STRETCHED, DEFIB CONDUCTOR FRACTURE (OVERSTRESS), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING OVERLAY COSMETIC ESC, OUTER TUBING ESC BREACH/BREACH (NON-ELECTRICAL), OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. (B)(4) PROXIMAL SEGMENT RETURNED AND ANALYZED. NO ANOMALIES FOUND, ALL CONDUCTORS STRETCHED, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC ESC, OUTER INSULAITON COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. ATTORNEY FURTHER ALLEGES AS A RESULT OF THE LEAD PATIENT "SUFFERED PHYSICAL INJURIES AND VARIOUS PHYSICAL MANIFESTATIONS OF EMOTIONAL DISTRESS ASSOCIATED WITH ONE OR MORE OF THE FOLLOWING: THE IMPLANTATION, RECALL, FAILURE, REMOVAL/REPLACEMENT, AND/OR INABILITY TO HAVE THE DEFECTIVE SPRINT FIDELIS LEAD REMOVED OR REPLACED." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN RESEARCHED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED WITH NO EPISODES PRIOR TO DEATH. DEVICE NOT TURNED OFF UNTIL SIX DAYS AFTER DEATH AND THERE WERE MULTIPLE EPISODES AND NOISE THAT WERE ON THE DEVICE, "BUT APPEAR TO BE AFTER THE PATIENT EXPIRED." IT WAS FURTHER REPORTED THAT THERE WERE ALSO EPISODES IN "THE LOG AT THE TOD, BUT NO RECORDS." IT WAS LATER ALLEGED BY ATTORNEY PATIENT "WAS IMPLANTED WITH A MEDTRONIC SPRINT FIDELIS LEAD WIRE SYSTEM, AND SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD" AND "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death