BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 18823047 · Received March 1, 2024

    Report

    Report Number
    3006630150-2024-01137
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 3, 2024
    Report Date
    April 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    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

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7080741. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7085608. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7085722. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 505640. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 26809467.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: (B)(4) MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7080741 PRODUCT FAMILY: DBS-EXTENSION UPN: (B)(4) MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7085608 PRODUCT FAMILY: DBS-EXTENSION UPN: (B)(4) MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7085722 PRODUCT FAMILY: DBS-IPG-R-MRI UPN: (B)(4) MODEL: DB-1216 SERIAL: (B)(6) BATCH: 505640 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: (B)(4) MODEL: DB-4600C SERIAL: N/A BATCH: 26809467

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE ENTIRE DBS SYSTEM DUE TO LEAD EROSION NEAR THE LEAD EXTENSION CONNECTOR SITE. THE EXPLANTED DEVICES WERE SENT FOR CULTURE. NO INFECTION SYMPTOMS WERE NOTICED AND THE CAUSE OF THE EROSION IS UNKNOWN. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE ENTIRE DBS SYSTEM DUE TO LEAD EROSION NEAR THE LEAD EXTENSION CONNECTOR SITE. THE EXPLANTED DEVICES WERE SENT FOR CULTURE. NO INFECTION SYMPTOMS WERE NOTICED AND THE CAUSE OF THE EROSION IS UNKNOWN. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CULTURES WERE NEGATIVE FOR ANY INFECTION AND EROSION WAS NOTICED WHILE THE PATIENT WAS AT THE HAIRDRESSER THREE DAYS PRIOR TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228053 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7080388 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention