BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 19264321 · Received May 7, 2024

    Report

    Report Number
    3006630150-2024-02941
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    September 29, 2023
    Report Date
    May 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER THE PAST SEVERAL MONTHS FROM DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2138700 MODEL: SC-2138-70 SERIAL: (B)(6) BATCH: 140079. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2208500 MODEL: SC-2208-50 SERIAL: (B)(6) BATCH: 183355.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS PAIN WORSENED PROGRESSIVELY DUE TO THE IPG NO LONGER TAKING A CHARGE AND REQUIRED LONGER CHARGING PERIODS. THE PATIENT WAS ALSO EXPERIENCING PAINFUL STIMULATION ON A NON-TARGETED AREA DUE TO HIGH IMPEDANCES AND SUSPECTED LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381304 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 175119

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention