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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 Bacterial Infection (1735); Fluid Discharge (2686)
Event Date 06/02/2023
Event Type  Injury  
Event Description
It was reported the patient experienced white fluid excreting from the deep brain stimulation (dbs) head incision site.The physician assessed the wound was infected.The patient was prescribed antibiotics and underwent a procedure where the leads and extensions were removed.No further information was obtained despite good faith efforts.
 
Manufacturer Narrative
Block b3: exact date unknown, event occurred somewhere between (b)(6) 2023 and (b)(6) 2023.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7104549.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7113958.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7113970.
 
Manufacturer Narrative
Block b3: exact date unknown, event occurred somewhere between 17may2023 and 02jun2023.Correction to the initial mdr in blocks b3 and d6b.
 
Event Description
It was reported the patient experienced white fluid excreting from the deep brain stimulation (dbs) head incision site.The physician assessed the wound was infected.The patient was prescribed antibiotics and underwent a procedure where the leads and extensions were removed.No further information was obtained despite good faith efforts.
 
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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 Key17656509
MDR Text Key322361075
Report Number3006630150-2023-05200
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 09/21/2023
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 Number7104322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/30/2023
Supplement Dates Manufacturer Received08/31/2023
Supplement Dates FDA Received09/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2023
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) Required Intervention;
Patient Age58 YR
Patient SexFemale
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