BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION SPECTRA

    MDR report key: 11335506 · Received February 16, 2021

    Report

    Report Number
    3006630150-2021-00509
    Event Type
    Death
    Date Received
    February 16, 2021
    Date of Event
    January 25, 2021
    Report Date
    April 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7080829 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SCS-LINEAR LEADS SERIAL: (B)(6) BATCH: 7079667 PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500 MODEL: SC-8216-50 SERIAL: (B)(6) BATCH: 7023552.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REPOSITIONING REVISION PROCEDURE AND PASSED AWAY THE SAME DAY. THE LEAD REVISION WAS DOCUMENTED IN MFG REPORT 3006630150-2021-00364. THE CAUSE OF DEATH IS UNKNOWN, BUT IT IS NOT BELIEVED TO BE DEVICE RELATED. THE REVISION PROCEDURE WENT WELL WITH NO ISSUES, AND THE PATIENT WAS DOING WELL DURING RECOVER AND WAS SENT HOME. AN AUTOPSY WILL BE PERFORMED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN THE RESULTS OF THE AUTOPSY DESPITE GOOD FAITH EFFORTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SCS-LINEAR LEADS; SERIAL: (B)(4); BATCH: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8216500; MODEL: SC-8216-50; SERIAL: (B)(4); BATCH: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REPOSITIONING REVISION PROCEDURE AND PASSED AWAY THE SAME DAY. THE LEAD REVISION WAS DOCUMENTED IN MFG REPORT 3006630150-2021-00364. THE CAUSE OF DEATH IS UNKNOWN, BUT IT IS NOT BELIEVED TO BE DEVICE RELATED. THE REVISION PROCEDURE WENT WELL WITH NO ISSUES, AND THE PATIENT WAS DOING WELL DURING RECOVER AND WAS SENT HOME. AN AUTOPSY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228369 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 202861 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death