BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 15529147 · Received October 3, 2022

    Report

    Report Number
    3006630150-2022-05211
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    September 6, 2022
    Report Date
    November 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE CARTESIA; UPN: UNK-M-DB-2202-45; MODEL: DB-2202-45; SERIAL: N/I; BATCH: N/I.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: VERCISE CARTESIA, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 20572575. BRAND NAME: VERCISE 8 CONTACT EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7044375. BRAND NAME: VERCISE 8 CONTACT EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7052109. BRAND NAME: SURETEK, UPN: M365DB4600C00, MODEL: DB-4600-C0, SERIAL: N/A, BATCH: 20565259. BRAND NAME: SURETEK, UPN: M365DB4600C00, MODEL: DB-4600-C0, SERIAL: N/A, BATCH: 20565480.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RECURRING INFECTION AT THE DEEP BRAIN STIMULATION (DBS) CRANIAL LEAD SITE. THE PATIENT WAS TO UNDERGO AN EXPLANT PROCEDURE. NO FURTHER INFORMATION REGARDING THE INFECTION, DEVICES OR PROCEDURE HAVE BEEN ABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RECURRING INFECTION AT THE DEEP BRAIN STIMULATION (DBS) CRANIAL LEAD SITE. THE PATIENT WAS TO UNDERGO A DBS EXPLANT PROCEDURE. NO FURTHER INFORMATION REGARDING THE INFECTION, DEVICES OR PROCEDURE HAS BEEN ABLE TO BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE INFECTION WAS AT THE LEAD AND LEAD EXTENSION SITES. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY. FURTHER INFORMATION REGARDING THIS EVENT AND THE PROCEDURE ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314293 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 20484034 08714729905288
    497367 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 20484034 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention