BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 17646688 · Received August 29, 2023

    Report

    Report Number
    3006630150-2023-05158
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    August 9, 2023
    Report Date
    December 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6) , LOT: 7100632 . PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138-550, MODEL: NM-3138-55, SERIAL: (B)(6) , LOT: 7110607 AND 7110660 . PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6) , LOT: 560119.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). LOT: 7100632. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138-550. MODEL: NM-3138-55. SERIAL: (B)(6) AND (B)(6). LOT: 7110607 AND 7110660. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). LOT: 560119.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS WOUND HAD NOT HEALED PROPERLY. THE LOCATION OF THE WOUND WAS ON THE LATERAL ASPECT OF THE SCALP, NEAR WHERE THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSION HEADERS MEET THE DBS LEADS. THE PATIENT REPORTS PICKING AT THE WOUND SINCE THE IMPLANT PROCEDURE, AND THE PHYSICIAN BELIEVES THIS CAUSED AN INFECTION. THE PATIENT UNDERWENT A WOUND DEBRIDEMENT PROCEDURE, WAS ADMINISTERED BACTRIM ANTIBIOTICS AND IS DOING WELL. A CULTURE WAS TAKEN WHICH CONFIRMED KLEBSIELLA AEROGENES. THE DEVICES REMAIN IMPLANTED AND THERE IS NO FURTHER COURSE OF ACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS WOUND HAD NOT HEALED PROPERLY. THE LOCATION OF THE WOUND WAS ON THE LATERAL ASPECT OF THE SCALP, NEAR WHERE THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSION HEADERS MEET THE DBS LEADS. THE PATIENT REPORTS PICKING AT THE WOUND SINCE THE IMPLANT PROCEDURE, AND THE PHYSICIAN BELIEVES THIS CAUSED AN INFECTION. THE PATIENT UNDERWENT A WOUND DEBRIDEMENT PROCEDURE, WAS ADMINISTERED BACTRIM ANTIBIOTICS AND IS DOING WELL. A CULTURE WAS TAKEN WHICH CONFIRMED KLEBSIELLA AEROGENES. THE DEVICES REMAIN IMPLANTED AND THERE IS NO FURTHER COURSE OF ACTION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS LEAD EXTENSION ERODED THROUGH THE SKIN. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT IS DOING FINE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058085 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7100456 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention