BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 11970557 · Received June 9, 2021

    Report

    Report Number
    3006630150-2021-02794
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLOCK APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2317-50 SERIAL: (B)(4). BATCH: 18308449/1830844.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS IPG WAS NON-FUNCTIONAL. ALL COMPONENTS WERE EXPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864703 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 19497531 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention