BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    MDR report key: 13067050 · Received December 22, 2021

    Report

    Report Number
    3006630150-2021-07191
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 12, 2021
    Report Date
    March 18, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220330C0, MODEL: DB-2203-30C, SERIAL: (B)(4), BATCH: 5000587.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB321655C0. MODEL: DB-3216-55C. SERIAL: (B)(6). BATCH: 5000341. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB321655C0. MODEL: DB-3216-55C. SERIAL: (B)(6). BATCH: 5000307.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A RIGHT BASAL GANGLIA HEMATOMA FOLLOWING A FALL FOUR DAYS POST-IMPLANT OF DEEP BRAIN STIMULATOR LEADS. THE PATIENT WAS ADMINISTERED MEDICATION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENTS STATUS IS UNKNOWN AS THE ISSUE IS ONGOING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A RIGHT BASAL GANGLIA HEMATOMA FOLLOWING A FALL FOUR DAYS POST-IMPLANT OF DEEP BRAIN STIMULATOR LEADS. THE PATIENT WAS ADMINISTERED MEDICATION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENTS STATUS IS UNKNOWN AS THE ISSUE IS ONGOING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON CUT THE EXTENSIONS FLUSH TO THE SCALP TO AVOID FURTHER SURGERY. THE SECOND STAGE OF THE IMPLANT WAS POSTPONED DUE TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A RIGHT BASAL GANGLIA HEMATOMA FOLLOWING A FALL FOUR DAYS POST-IMPLANT OF DEEP BRAIN STIMULATOR LEADS. THE PATIENT WAS ADMINISTERED MEDICATION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENTS STATUS IS UNKNOWN AS THE ISSUE IS ONGOING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON CUT THE EXTENSIONS FLUSH TO THE SCALP TO AVOID FURTHER SURGERY. THE SECOND STAGE OF THE IMPLANT WAS POSTPONED DUE TO THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED EVENT HAS RESOLVED WITH RESIDUAL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962846 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2203-30C 5000581

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| O