BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION

    MDR report key: 6859320 · Received September 12, 2017

    Report

    Report Number
    3006630150-2017-03343
    Event Type
    Death
    Date Received
    September 12, 2017
    Report Date
    August 18, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH: (B)(6) 2015 (EXACT DATE UNKNOWN). DATE OF EVENT: (B)(6) 2015 (EXACT DATE UNKNOWN). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8216-50, SERIAL/LOT: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50 CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION CAN BE OBTAINED REGARDING THE REPORTED EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY. THE CAUSE OF THE PATIENT PASSING IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT PASSED AWAY. THE CAUSE OF THE PATIENT PASSING IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638157 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 Death