BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 11569260 · Received March 25, 2021

    Report

    Report Number
    3006630150-2021-01211
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5180051. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7055954. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55: SERIAL:(B)(4) BATCH: 7071358. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: (B)(4), MODEL: DB-1200-S, SERIAL: (B)(4), BATCH: 742490.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION THAT ORIGINATED AT THE LEAD AND LEAD EXTENSION CONNECTOR SITE AND THE SYMPTOMS INCLUDED ITCHING AND REDNESS AT THE SCALP. THE SOURCE OF THE INFECTION IS BELIEVED TO BE THAT A FAMILY MEMBER REMOVED SOME SUTURES THAT HAD BEEN LEFT IN SITU. THE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED AND THE PATIENT TREATED WITH ANTIBIOTICS. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466977 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 5178555 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention