BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 11069882 · Received December 23, 2020

    Report

    Report Number
    3006630150-2020-06388
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    December 1, 2020
    Report Date
    March 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7072229 CORRECTION TO INITIAL MDR IN BLOCK D1 AND D4.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MILD WORD FINDING DISORDER. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE EVENT IS RESOLVING. THE EVENT WAS ASSESSED WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND NOT DEVICE OR STIMULATION RELATED. ADDITIONAL INFORMATION WAS RECEIVED THAT ON 01DEC2020 THE PATIENT HAD EDEMA AROUND THE LEFT ELECTRODE WITH WORD FINDING DISORDERS. THE EVENT WAS ASSESSED WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND NOT DEVICE OR STIMULATION RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MILD WORD FINDING DISORDER. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE EVENT IS RESOLVING. THE EVENT WAS ASSESSED WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND NOT DEVICE OR STIMULATION RELATED. ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2020 THE PATIENT HAD EDEMA AROUND THE LEFT ELECTRODE WITH WORD FINDING DISORDERS. THE EVENT WAS ASSESSED WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND NOT DEVICE OR STIMULATION RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MILD WORD FINDING DISORDER. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE EVENT IS RESOLVING. THE EVENT WAS ASSESSED WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND NOT DEVICE OR STIMULATION RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534277 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 7072229

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention