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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 Problems Hemorrhage/Bleeding (1888); Confusion/ Disorientation (2553)
Event Date 10/20/2023
Event Type  Injury  
Event Description
It was reported that the patient experienced a small cortical bleed during a procedure to place the deep brain stimulation (dbs) leads.Although the patient was initially discharged from the hospital, he was later readmitted after he experienced confusion.The patient was observed by neurology and referred to a rehabilitation center.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7109061.
 
Manufacturer Narrative
Correction to the initial mdr in block h6.
 
Event Description
It was reported that the patient experienced a small cortical bleed during a procedure to place the deep brain stimulation (dbs) leads.Although the patient was initially discharged from the hospital, he was later readmitted after he experienced confusion.The patient was observed by neurology and referred to a rehabilitation center.
 
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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 sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key18166547
MDR Text Key328477786
Report Number3006630150-2023-07169
Device Sequence Number1
Product Code NHL
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/05/2024
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 Number7108942
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/31/2023
Initial Date FDA Received11/18/2023
Supplement Dates Manufacturer Received01/12/2024
Supplement Dates FDA Received02/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2023
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;
Patient Age64 YR
Patient SexMale
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