BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 21911338 · Received April 25, 2025

    Report

    Report Number
    3006630150-2025-02786
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    April 1, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 783634 UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 5174094, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 5174103, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 5171936. UDI: (B)(4). PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB1200S0. MODEL: DB-1200-S. SERIAL: (B)(6). BATCH: 740321. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES ON THE LEFT SIDE LEAD EXTENSION ON CONTACTS ONE AND THREE WHEREIN THE PATIENTS TREMOR SYMPTOMS WERE NOT CONTROLLED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS AND IMPLANTABLE PULSE GENERATOR (IPG) WERE REPLACED. AFTER THE PROCEDURE THE PHYSICIAN ASSESSED THAT THE HIGH IMPEDANCES WERE NOT RESOLVED. THE PHYSICIAN DETERMINED THE HIGH IMPEDANCES WERE ON THE LEAD WHICH REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT CONTINUED TO EXPERIENCE HIGH IMPEDANCE ISSUES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG AND LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES ON THE LEFT SIDE LEAD EXTENSION ON CONTACTS ONE AND THREE WHEREIN THE PATIENTS TREMOR SYMPTOMS WERE NOT CONTROLLED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS AND IMPLANTABLE PULSE GENERATOR (IPG) WERE REPLACED. AFTER THE PROCEDURE THE PHYSICIAN ASSESSED THAT THE HIGH IMPEDANCES WERE NOT RESOLVED. THE PHYSICIAN DETERMINED THE HIGH IMPEDANCES WERE ON THE LEAD WHICH REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825391 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION NM-3138-55 7070332 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention