BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO DR

    MDR report key: 1700044 · Received May 27, 2010

    Report

    Report Number
    6000144-2010-02044
    Event Type
    Death
    Date Received
    May 27, 2010
    Date of Event
    March 5, 2010
    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
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT HAD PASSED THROUGH PRISON SECURITY 3 WEEKS PRIOR TO HER DEATH. AFTER HAVING PASSED THROUGH SECURITY, PATIENT "WAS WEAKER" AND "ALL OF A SUDDEN SHE WENT DOWNHILL." THE PATIENT'S DAUGHTER IS QUESTIONING IF THE SECURITY WAND COULD HAVE AFFECTED/DAMAGED THE DEVICE. FOLLOW UP WITH THE CLINIC REPORTED THE PATIENT HAD LAST BEEN SEEN BY THEM IN (B) (6) 2007 AND THEY HAD NO CONCERN REGARDING DEVICE OR LEAD PERFORMANCE PRIOR TO THE PATIENT'S DEATH. IT WAS LATER REPORTED THE PATIENT SUFFERED A FATAL HEART ATTACK 3 WEEKS AFTER HAVING BEEN "WANDED AT HER IMPLANT SITE" AND THERE WAS A QUESTION IF THE WANDING HAD DAMAGED THE IMPLANT. IT WAS UNKNOWN IF THE PATIENT HAD BEEN PACEMAKER DEPENDENT, BUT IT WAS REPORTED HER "ARTERIES NOT SUFFICIENT FOR HEART TO FUNCTION WITHOUT ASSISTANCE."

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT HAD PASSED THROUGH PRISON SECURITY 3 WEEKS PRIOR TO HER DEATH. AFTER HAVING PASSED THROUGH THE SECURITY, PATIENT "WAS WEAKER" AND "ALL OF A SUDDEN SHE WENT DOWNHILL." THE PATIENT'S DAUGHTER IS QUESTIONING IF THE SECURITY WAND COULD HAVE AFFECTED/DAMAGED THE DEVICE. 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 BY THE PATIENT'S DAUGHTER THAT THE PATIENT HAD PASSED THROUGH PRISON SECURITY 3 WEEKS PRIOR TO HER DEATH. AFTER HAVING PASSED THROUGH THE SECURITY, PATIENT "WAS WEAKER" AND "ALL OF A SUDDEN SHE WENT DOWNHILL." THE PATIENT'S DAUGHTER IS QUESTIONING IF THE SECURITY WAND COULD HAVE AFFECTED/DAMAGED THE DEVICE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE CLINIC REPORTED THE PATIENT HAD LAST BEEN SEEN BY THEM IN (B) (6) 2007, AND THEY HAD NO CONCERN REGARDING DEVICE OR LEAD PERFORMANCE PRIOR TO THE PATIENT'S DEATH.

    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 72 YR Death