Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-2202-30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Cognitive Changes (2551); Confusion/ Disorientation (2553); No Code Available (3191); Hallucination (4428); Swelling/ Edema (4577)
Event Date 10/09/2020
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: (b)(4), model : db-2202-45, serial : (b)(4), lot: 7073540.
 
Event Description
It was reported that the patient experienced edema a day after a dbs lead implant procedure, prior to being discharged from the hospital.The patient was administered cortisone.The devices remain implanted in the patient.The physician suspected the event may be due to a reaction to the lead material.
 
Manufacturer Narrative
Correction to the initial mdr in blocks; b1: should have only stated adverse event.H6: should have had block h6 patient code 3191: no code available.Block h6 patient code 3191: no code available was used as there is no equivalent fda code for additional intervention.
 
Event Description
It was reported that the patient experienced edema a day after a dbs lead implant procedure, prior to being discharged from the hospital.The patient was administered cortisone.The devices remain implanted in the patient.The physician suspected the event may be due to a reaction to the lead material.Additional information was received that 14 days post-implant, the patient experienced a serious peri-lead edematous reaction with psychiatric complications which included severe confusion.A continuous tomography scan of the head showed hypodense white matter changes around the puncture channel on both sides, more on the left than right side.The patient was given medication and repeat ct exams were performed.The hospitalization was prolonged, however, the event is resolving.The physician assessed this event to have a probable relationship to the procedure, possibly related to device stimulation, and not related to device hardware.
 
Event Description
It was reported that the patient experienced edema a day after a dbs lead implant procedure, prior to being discharged from the hospital.The patient was administered cortisone.The devices remain implanted in the patient.The physician suspected the event may be due to a reaction to the lead material.Additional information was received that 14 days post-implant, the subject experienced a serious peri-lead edematous reaction with psychiatric complications including severe confusion.A continuous tomography scan of the head showed hypodense white matter changes around the puncture channel on both sides, more on the left than right side.The patient was given medication and repeat ct exams were performed.The hospitalization was prolonged, however, the event is resolving.Additional information was received that the patient also developed psychiatric complications of apathy, neurocognitive impairment, and temporary psychosis with hallucinations due to the event.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), lot: 7073540.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: 7077181.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: 7077182.Product family: dbs-ipg, upn: m365db12000, model: db-1200, serial: (b)(6), lot: 742711.
 
Event Description
It was reported that the patient experienced edema a day after a dbs lead implant procedure, prior to being discharged from the hospital.The patient was administered cortisone.The devices remain implanted in the patient.The physician suspected the event may be due to a reaction to the lead material.Additional information was received that 14 days post-implant, the subject experienced a serious peri-lead edematous reaction with psychiatric complications including severe confusion.A continuous tomography scan of the head showed hypodense white matter changes around the puncture channel on both sides, more on the left than right side.The patient was given medication and repeat ct exams were performed.The hospitalization was prolonged, however, the event is resolving.Additional information was received that the patient also developed psychiatric complications of apathy, neurocognitive impairment, and temporary psychosis with hallucinations due to the event.Additional information was received that the patient underwent a system explant procedure.The edema still exists and the patient is disabled due to the edema.The patient requires a full-time nurse and physiotherapy.No further course of action is anticipated.The devices will not be returned as they were disposed of by the medical facility.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERCISE CARTESIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key10891362
MDR Text Key217905926
Report Number3006630150-2020-05729
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729905271
UDI-Public08714729905271
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 05/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/20/2022
Device Model NumberDB-2202-30
Device Catalogue NumberDB-2202-30
Device Lot Number7071266
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received11/24/2020
05/24/2021
04/21/2023
Supplement Dates FDA Received12/17/2020
06/10/2021
05/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Other;
Patient Age64 YR
Patient SexMale
-
-