BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION MONTAGE MRI IPG STERILE KIT

    MDR report key: 7629443 · Received June 22, 2018

    Report

    Report Number
    3006630150-2018-02203
    Event Type
    Death
    Date Received
    June 22, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 22, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-50 SERIAL #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM THE DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY DUE TO AN UNKNOWN REASON. THE CIRCUMSTANCES OF THE DEATH ARE UNKNOWN AND NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472402 PRECISION MONTAGE MRI IPG STERILE KIT SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 NA 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death