BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 21639087 · Received March 18, 2025

    Report

    Report Number
    3006630150-2025-01633
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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: 7120815. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7113487. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7113276. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 595715. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C SERIAL: NA BATCH: 33034014

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AND EROSION AT THE CONNECTION SITE OF THE LEAD EXTENSION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED, AND ANTIBIOTICS WERE ADMINISTERED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE MEDICAL FACILITY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284075 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION NM-3138-55 7121938 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| H