BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 19231160 · Received May 2, 2024

    Report

    Report Number
    3006630150-2024-02804
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 8, 2024
    Report Date
    July 9, 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

    CORRECTION TO THE INITIAL MDR IN BLOCK(S): B1 AND H6. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB1200S0. MODEL: DB-1200-S. SERIAL: (B)(6). BATCH: 745290. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4605C0. MODEL: DB-4605C. BATCH: 27164554. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7083240. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7082143. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7086055.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL:DB-4600C, SERIAL: N/A, BATCH: 26287597.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION OVER THE LEFT BURR HOLE COVER AND LEAD EXTENSION SITE, AS HE HAD A NON-HEALING WOUND OVER THE BURR HOLE COVER CAP AND THE LEAD EXTENSION BEHIND HIS EAR. THE LEFT BURR HOLE COVER AND LEAD WERE EXPLANTED. A PORT PLUG WAS PLACED IN THE LEFT EXTENSION HEADER. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER. IT WAS NOTED THAT THERE WERE NO DEVICE ISSUES AND THE PATIENT WAS EXPECTED TO FULLY RECOVER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD BEEN PLACED ON ANTIBIOTICS, KEFLEX, PRIOR TO THE EXPLANT OF THE LEFT BURR HOLVE COVER AND LEAD EXTENSION. THE PATIENT ALSO HAD DEHISCENCE OVER THE LEFT BURR HOLE COVER AND LEAD EXTENSION BEHIND HIS EAR. FOLLOWING THAT EXPLANT, CULTURES WERE TAKEN THAT REVEALED THAT THE PATIENT HAD DEVELOPED PSEUDOMONAS AND WAS PLACED ON SIX WEEKS OF LEVOFLOXACIN. IT WAS ASSESSED BY THE PHYSICIAN THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE EXTENSION SITE THAT WAS NOT ABLE TO BE TREATED AS WELL AS RE-DEHISCENCE. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT. ADDITIONAL CULTURES WERE TAKEN, AND THEY TOO REVEALED PSEUDOMONAS. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION OVER THE LEFT BURR HOLE COVER AND LEAD EXTENSION SITE, AS HE HAD A NON-HEALING WOUND OVER THE BURR HOLE COVER CAP AND THE LEAD EXTENSION BEHIND HIS EAR. THE LEFT BURR HOLE COVER AND LEAD WERE EXPLANTED. A PORT PLUG WAS PLACED IN THE LEFT EXTENSION HEADER. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER. IT WAS NOTED THAT THERE WERE NO DEVICE ISSUES AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402901 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7079028 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention