BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 4970781 · Received August 5, 2015

    Report

    Report Number
    9614453-2015-01755
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    December 30, 2014
    Report Date
    September 10, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY TWO MONTHS AFTER DEVELOPING INFECTION AND ENDOCARDITIS. THE INFORMATION REPORTED THE PATIENT DIED "AFTER DETERIORATION OF GENERAL CONDITION." ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THE PATIENT'S DEVICE SYSTEM WAS EXPLANTED PRIOR TO DEATH. THE CAUSE OF DEATH WAS DUE TO RENAL INSUFFICIENCY AND RESPIRATORY FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR WEEKS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE PATIENT DEVELOPED STAPHYLOCOCCUS AUREUS ENDOCARDITIS. THE INFECTION WAS REPORTED TO BE RELATED TO THE IMPLANT PROCEDURE. THE PATIENT WAS HOSPITALIZED AND TREATED WITH INTRAVENOUS AND ORAL ANTIBIOTICS. THE DEVICE SYSTEM REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513193 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death| H| R