BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASKU

    MDR report key: 1932038 · Received December 17, 2010

    Report

    Report Number
    2182208-2010-01108
    Event Type
    Death
    Date Received
    December 17, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. WE HAVE NO INFORMATION FROM A HEALTH CARE PROFESSIONAL TO SUGGEST THE DEATH WAS DEVICE RELATED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. THE CAUSE OF DEATH HAS BEEN RESEARCHED BUT HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES PATIENT "DIED AS DIRECT RESULT OF THE USE OF THE DEFECTIVE MEDTRONIC PRODUCT" AND "SUSTAINED A DIRECT INJURY BY THE USE OF THE DEFECTIVE MEDTRONIC PRODUCT." FURTHER ALLEGES PATIENT SUSTAINED OR IN IMMINENT RISK OF "SUSTAINING UNCONTROLLED HEART ARRHYTHMIAS, PULSE CHANGES, ELECTRIC SHOCKS, CARDIOVASCULAR HEALTH COMPLICATIONS, REPEATED SURGICAL PROCEDURES, HEART FAILURE, AND DEATH" AND "WILL CONTINUE TO SUSTAIN HIGH ANXIETY, FEARS OF IMMINENT DEATH, DEPRESSION." ALLEGES PATIENT WAS "IMPLANTED WITH A CARDIAC PACEMAKER/DEFIBRILLATOR COMBINATION (AN "ICD"). THE ICD WAS ATTACHED TO (PATIENT HEART) WITH A LEAD WIRE SYSTEM MANUFACTURED BY MEDTRONIC" AND AS A DIRECT RESULT OF THE SPRINT FIDELIS LEAD, PATIENT "SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, AND ECONOMIC LOSSES AND CONSEQUENTIAL DAMAGES."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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC, INC. ICD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death