BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICK

    MDR report key: 21227808 · Received January 24, 2025

    Report

    Report Number
    3006630150-2025-00187
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729793267
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI UPN: M365SC12160, MODEL: SC-1216, SERIAL: (B)(6), BATCH: 772360. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7152403/7147400.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD HEMATOMA, PAIN, AND A RED BUMP THAT WAS NOT HEALING AT THE ANCHOR SITE. THE PHYSICIAN DRAINED THE AREA UNDER X-RAY. FOLLOWING THE PROCEDURE, PUS WAS NOTED AT THE ANCHOR SITE AND INFECTION DEVELOPED AT THE BATTERY SITE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS ADMINISTERED WITH ANTIBIOTICS. ALL DEVICE COMPONENTS WERE REMOVED AND WERE NOT RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708142 CLICK STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-4316 35008206 08714729793267

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention