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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

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BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-2202-45
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 06/30/2023
Event Type  Injury  
Event Description
It was reported that two days after the initial deep brain stimulation lead implant procedure, the patient experienced an event of hypertensive crisis.The patient was seen in the emergency department due to facial droop which was initially suspected to be a stroke but was later noted to be due to the parkinsons medication not working.The computed tomography (ct) scan found no significant findings.The hypertension was noted to be uncomplicated, and the event resolved, however, the patient was kept in the hospital longer as stage 2 of the implant procedure had been scheduled several days out.The patient was discharged the day after the stage 2 implant procedure in stable condition.
 
Event Description
It was reported that two days after the initial lead implant procedure, the patient experienced an event of hypertensive crisis.He was seen in the emergency department due to facial droop which was initially suspected to be a stroke but was later noted to be due to the parkinsons medication not working.The computed tomography (ct) scan found no significant findings.The hypertension was noted to be uncomplicated, and the event resolved, however, the patient was kept in the hospital longer as the stage 2 of the implant procedure had been scheduled several days out.The patient was discharged the day after the stage 2 implant procedure in stable condition.
 
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: 7097433.
 
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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 Key17431777
MDR Text Key320114620
Report Number3006630150-2023-04475
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729905288
UDI-Public08714729905288
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/16/2023
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? No
Device Operator Lay User/Patient
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7097621
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/17/2023
Initial Date FDA Received08/01/2023
Supplement Dates Manufacturer Received08/16/2023
Supplement Dates FDA Received08/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2022
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) Required Intervention;
Patient Age71 YR
Patient SexMale
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