BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20869024 · Received December 6, 2024

    Report

    Report Number
    3006630150-2024-08517
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 13, 2023
    Report Date
    December 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2208500, MODEL: SC-2208-50, SERIAL: (B)(6), BATCH: 200082/197380/189754/167344.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER HOLDING A CHARGE, AND THE LEADS HAD MIGRATED RESULTING TO DECREASED COVERAGE OF PAINFUL AREAS. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051428 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 18055323 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention