BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 17686593 · Received September 5, 2023

    Report

    Report Number
    3006630150-2023-05305
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    October 1, 2021
    Report Date
    September 5, 2023
    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 Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2316700, MODEL: SC-2316-70, SERIAL: (B)(6), BATCH: 21539173; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2316700, MODEL: SC-2316-70, SERIAL: (B)(6), BATCH: 21510774; PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072751; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072661; PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3400300, MODEL: SC-3400-30, SERIAL: (B)(6), BATCH: 2000019085; PRODUCT FAMILY: SCS-SPLITTERS; UPN: M365SC3400300, MODEL: SC-3400-30, SERIAL: (B)(6), BATCH: 2000019048.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A LACK OF BENEFIT FROM THE THERAPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL SCS SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122293 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20962213 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention