BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 22146296 · Received June 4, 2025

    Report

    Report Number
    3006630150-2025-03949
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7130330 UDI: 08714729820765. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7124465. UDI: 08714729905288. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7124930. UDI: 08714729905288.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN ALLERGIC REACTION IN THE NECK AREA AT THE SITE OF THE LEAD EXTENSION WHEREIN CAUSING WOUND DEHISCENCE AND THE LEAD EXTENSION TO ERODE THROUGH THE SKIN. THERE WERE SIGNS OF SWELLING, INFLAMMATION AND EDEMA. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS AND LEADS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WAS NOT RETURNED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DATE OF THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723772 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION NM-3138-55 7130341 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention