BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 17176918 · Received June 21, 2023

    Report

    Report Number
    3006630150-2023-03586
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    May 24, 2023
    Report Date
    July 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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), BATCH: 7102459. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: NULL, BATCH: 30994077.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 563384.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT PRESENTED WITH PROGRESSIVE HEMIPARALYSIS ONE SIDED WEAKNESS AND AN INFECTION WHICH WAS EVIDENT BY HIS ELEVATED ESR AND CRP RATES. A COMPUTED TOMOGRAPHY CT SCAN WAS PERFORMED. AFTER REVIEWING THE CT IMAGE, THE PHYSICIAN ASSESSED RIGHT SIDED HYGROMA OR LEAKAGE OF CSF, POSTERIOR TO THE RIGHT BURR HOLE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE CSF FLUID WAS EVACUATED. THERE WAS A FOLLOW UP CT IMAGE PERFORMED AND REVEALED THAT THE BLEED APPEARED TO BE STABLE. THE PATIENT WAS ADMITTED TO THE ICU TO BE TREATED FOR ASPIRATION PNEUMONIA, LEUKOCYTOSIS, ENCEPHALOPATHY AND HAD AN NG TUBE PLACED WITH CONCERNS FOR BOWEL ISSUES AND REMAINED INTUBATED. THE PATIENT WAS LATER WITHDRAWN FROM LIFE SUPPORT AND PASSED AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT PRESENTED WITH PROGRESSIVE HEMIPARALYSIS ONE SIDED WEAKNESS AND AN INFECTION WHICH WAS EVIDENT BY HIS ELEVATED ESR AND CRP RATES. A COMPUTED TOMOGRAPHY CT SCAN WAS PERFORMED. AFTER REVIEWING THE CT IMAGE, THE PHYSICIAN ASSESSED RIGHT SIDED HYGROMA OR LEAKAGE OF CSF, POSTERIOR TO THE RIGHT BURR HOLE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE CSF FLUID WAS EVACUATED. THERE WAS A FOLLOW UP CT IMAGE PERFORMED AND REVEALED THAT THE BLEED APPEARED TO BE STABLE. THE PATIENT WAS ADMITTED TO THE ICU TO BE TREATED FOR ASPIRATION PNEUMONIA, LEUKOCYTOSIS, ENCEPHALOPATHY AND HAD AN NG TUBE PLACED WITH CONCERNS FOR BOWEL ISSUES AND REMAINED INTUBATED. THE PATIENT WAS LATER WITHDRAWN FROM LIFE SUPPORT AND PASSED AWAY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN ASSESSED THAT THE INFECTION WAS NOT DEVICE RELATED AS THE PATIENT DEVELOPED A SUBDURAL HEMATOMA. THE HEMATOMA IMPACTED THE PATIENT'S ABILITY TO SWALLOW, LEADING TO ASPIRATION PNEUMONIA AND SUBSEQUENT DEATH. ALSO RECEIVED THE MODEL AND SERIAL NUMBER FOR THE IPG IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029350 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7100917 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| H