BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 20850148 · Received December 4, 2024

    Report

    Report Number
    3006630150-2024-08387
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    October 9, 2024
    Report Date
    March 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729836544
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: 7123001. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7122879. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB220145DC0. MODEL: DB-2201-45DC. SERIAL: (B)(6). BATCH: 7072513. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: 585698.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4605-C. BATCH: 32118923. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4605C0. MODEL: DB-4605-C. BATCH: 29206351. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4605-C. BATCH: 32546120.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AT THE HEADER BLOCK OF THE LEAD EXTENSION AND UNDERWENT A FULL SYSTEM EXPLANT. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE DEVICES WERE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AT THE HEADER BLOCK OF THE LEAD EXTENSION AND UNDERWENT A FULL SYSTEM EXPLANT. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE DEVICES WERE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AT THE HEADER BLOCK OF THE LEAD EXTENSION AND UNDERWENT A FULL SYSTEM EXPLANT. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE DEVICES WERE DISCARDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS COLLECTED AND WILL BE SENT OUT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871723 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2201-45DC 7074271 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention