BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 15814428 · Received November 17, 2022

    Report

    Report Number
    3006630150-2022-06315
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    October 17, 2022
    Report Date
    December 12, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), LOT: 7085230; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), LOT: 7091535; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), LOT: 7091398; PRODUCT FAMILY: DB-4600C, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: (B)(4), LOT: 27730335; PRODUCT FAMILY: DB-4600C, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: (B)(4), LOT: 27648293; PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12000, MODEL: DB-1200, SERIAL: N/I, LOT: N/I.

    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). LOT: 7085230. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). LOT: 7091535. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). LOT: 7091398 PRODUCT FAMILY: DB-4600C. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: (B)(6). LOT: 27730335. PRODUCT FAMILY: DB-4600C. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: (B)(6). LOT: 27648293.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE DEEP BRAIN STIMULATION (DBS) LEAD SITE IN THE HEAD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE SYSTEM WAS REMOVED. THE PHYSICIAN ASSESSED THE EVENT MAY BE RELATED TO THE DEVICES. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE DEEP BRAIN STIMULATION (DBS) LEAD SITE IN THE HEAD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE SYSTEM WAS REMOVED. THE PHYSICIAN ASSESSED THE EVENT MAY BE RELATED TO THE DEVICES. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT IT IS UNKNOWN HOW THE INFECTION COULD BE DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853389 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7084432 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention