BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 13070616 · Received December 23, 2021

    Report

    Report Number
    3006630150-2021-07196
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    October 20, 2021
    Report Date
    March 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    PMA / PMN Number
    P150031
    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 (S) INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220330C0, MODEL: DB-2203-30C, SERIAL: (B)(6), BATCH: 5000355.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT (S) INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB220330C0 MODEL: DB-2203-30C SERIAL: (B)(6) BATCH: 5000355 PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB321655C0 MODEL: DB-3216-55C SERIAL:(B)(6) AND 5000249 BATCH: 5000189 AND 5000249

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NON-SERIOUS ADVERSE EVENT OF SCALP ERYTHEMA WITH MILD SEVERITY. THE PATIENT WAS GIVEN MEDICATION AND THE EVENT RESOLVED. IT WAS ALSO STATED THAT THERE WAS NO SIGN OF INFECTION. THE RELATIONSHIP TO THE PROCEDURE AND THE DEVICE WAS REPORTED TO BE PROBABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NON-SERIOUS ADVERSE EVENT OF SCALP ERYTHEMA WITH MILD SEVERITY. THE PATIENT WAS GIVEN MEDICATION AND THE EVENT RESOLVED. IT WAS ALSO STATED THAT THERE WAS NO SIGN OF INFECTION. THE RELATIONSHIP TO THE PROCEDURE AND THE DEVICE WAS REPORTED TO BE PROBABLE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS GIVEN OVER THE COUNTER MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NON-SERIOUS ADVERSE EVENT OF SCALP ERYTHEMA WITH MILD SEVERITY. THE PATIENT WAS GIVEN MEDICATION AND THE EVENT RESOLVED. IT WAS ALSO STATED THAT THERE WAS NO SIGN OF INFECTION. THE RELATIONSHIP TO THE PROCEDURE AND THE DEVICE WAS REPORTED TO BE PROBABLE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS GIVEN OVER THE COUNTER MEDICATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE RELATIONSHIP OF THE EVENT TO THE LEAD EXTENSIONS WAS REPORTED AS PROBABLE, AND THE RELATIONSHIP TO THE LEADS WAS UPDATED TO NOT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968242 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2203-30C 5000358
    1968248 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2203-30C 5000358

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention