BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA

    MDR report key: 7979795 · Received October 18, 2018

    Report

    Report Number
    3006630150-2018-61422
    Event Type
    Death
    Date Received
    October 18, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 18, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 21256334. REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5067154. REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-30, SERIAL: (B)(4), BATCH: 5057353. REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 5070438. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY. DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED ON (B)(6) 2018 AND WAS ADMITTED FOR TWO DAYS FOLLOWING SURGERY AS PART OF STANDARD PROTOCOL. THE FINAL WOUND CHECK PRIOR TO DISCHARGE WAS UNREMARKABLE. ON (B)(6) 2018 THAT PATIENT DIED AS AN IN PATIENT IN (B)(6) HOSPITAL IN (B)(6), ACT DUE TO SEPTIC SHOCK, APPARENTLY SECONDARY TO INFECTION OF THE IPG. UPON FOLLOW UP WITH PHYSICIAN'S ASSISTANT, THE PATIENT BEGAN EXPERIENCING PAIN IN THE RIGHT LEG, APPROXIMATELY WITHIN THE PAST 1-2 WEEKS PRIOR TO DATE OF DEATH. THE PATIENT CHECKED INTO THE EMERGENCY DEPARTMENT OF (B)(6) HOSPITAL ON (B)(6) 2018 WITH PAIN IN RIGHT LEG, RADIATING TO RIGHT LOW BACK AT THE IPG POCKET SITE. THE PHYSICIAN WAS NOTIFIED OF THE PATIENT'S ADMISSION ON (B)(6) 2018. PATIENT HAD AN EXPLANT OF THE SCS SYSTEM ON (B)(6) 2018 AND DIED ON (B)(6) 2018 DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822435 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 203732 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| R