BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASKU

    MDR report key: 1933094 · Received December 20, 2010

    Report

    Report Number
    2649622-2010-15347
    Event Type
    Death
    Date Received
    December 20, 2010
    Date of Event
    June 12, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. FURTHER ALLEGES PATIENT WAS "SEVERELY AND PERMANENTLY INJURED, AND/OR HAS BEEN EXPOSED TO RISK OF SEVERE AND PERMANENT INJURY, AND WILL REQUIRE MORE CONSTANT AND CONTINUOUS MEDICAL MONITORING AND TREATMENT THAN PRIOR TO HIS IMPLANTATION OF DEFENDANT'S SPRINT FIDELIS LEAD WIRES" AND PATIENT EXPERIENCED AND OR IS "AT RISK OF EXPERIENCING SERIOUS AND DANGEROUS SIDE EFFECTS INCLUDING, BUT NOT LIMITED TO, PAINFUL ELECTRIC SHOCKS TO THE HEART, PHANTON SHOCKS TO THE HEART, CARDIAC ARREST, DEATH, AND/OR SUCH OTHER SIDE EFFECTS AS SHORTNESS OF BREATH, SHAKINESS, HEADACHE, DIZZINESS, PALE SKIN COLOR, SWEATING, AS WELL AS OTHER SEVERE AND PERSONAL INJURIES WHICH ARE PERMANENT AND LASTING IN NATURE, PHYSICAL PAIN AND MENTIAL ANGUISH, INCLUDING DIMINISHED ENJOYMENT OF LIFE, AS WELL AS THE NEED FOR LIFELONG MEDICAL TREATMENT, MONITORING AND/OR MEDICATIONS, AND FEAR OF DEVELOPING ANY OF THE ABOVE NAMED HEALTH CONSEQUENCES." 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

    ATTORNEY ALLEGES PATIENT WAS IMPLANTED WITH A DEVICE WITH "A DEFECTIVE SPRINT FIDELIS LEAD WIRE" AND AS A RESULT OF THE LEAD, SUFFERED INJURIES "WHICH RESULTED IN HIS DEATH ON (B)(6) 2007."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. LEAD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death