BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 25062405 · Received May 1, 2026

    Report

    Report Number
    3006630150-2026-02837
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    March 19, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE RETAINED AND DISPOSED OF BY THE FACILITY AND NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. HOWEVER, THE REPORTED SYMPTOMS OF REDNESS AND SWELLING IN THE DEVICE IMPLANT AREA WERE CONFIRMED THROUGH MEDIA INSPECTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF THE IMAGES PROVIDED FROM THE FIELD SHOWED REDNESS AND SWELLING IN THE DEVICE IMPLANT AREA. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AND STATES THAT LEAD, LEAD EXTENSION (INCLUDING LEAD EXTENSION HEADER) AND NEUROSTIMULATOR EROSION OR MIGRATION, IMPLANT SITE COMPLICATIONS SUCH AS PAIN, POOR HEALING, REDNESS, WARMTH, SWELLING OR WOUND REOPENING AND PAIN, HEADACHE OR DISCOMFORT, TRANSIENT OR PERSISTENT, INCLUDING SYMPTOMS DUE TO NEUROSTIMULATION ARE KNOWN RISK WITH THE USE OF DEEP BRAIN STIMULATION. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: NM-3138-55 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7131166 MODEL/CATALOG DESCRIPTION: 55CM 8 CONTACT EXTENSION UNIQUE IDENTIFIER (UDI) #:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SORENESS IN THE NECK AND HEAD AREA AT THE LOCATION OF THE EXTENSION HEADERS. THE PATIENT REPORTED DISCOMFORT, PAIN, SWELLING, AND REDNESS. TWELVE DAYS AFTER THE INITIAL REPORT, THE PHYSICIAN INFORMED THAT THE PATIENT'S EXTENSIONS HAD ERODED THROUGH THE SKIN AND THAT THE PATIENT WAS SCHEDULED FOR REVISION SURGERY. THE PATIENT UNDERWENT A LEAD EXTENSIONS EXPLANT. THE PATIENT WAS PLACED ON ANTIBIOTICS AND CULTURES WERE TAKEN BUT RESULTS WERE NOT DISCLOSED. POSTOPERATIVELY, THE PATIENT'S MOTOR SYMPTOMS REMAINED UNCONTROLLED DUE TO INACTIVE DBS SYSTEM. THE DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, AS THEY WERE RETAINED AND DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336759 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION NM-3138-55 7132156 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention