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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 Erosion (1750)
Event Date 02/03/2024
Event Type  Injury  
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7080741.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7085608.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7085722.Product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: (b)(6), batch: 505640.Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 26809467.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure to explant the entire dbs system due to lead erosion near the lead extension connector site.The explanted devices were sent for culture.No infection symptoms were noticed and the cause of the erosion is unknown.The patient was doing well post-operatively.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: (b)(4) model: db-2202-45 serial: (b)(6) batch: 7080741 product family: dbs-extension upn: (b)(4) model: nm-3138-55 serial: (b)(6) batch: 7085608 product family: dbs-extension upn: (b)(4) model: nm-3138-55 serial: (b)(6) batch: 7085722 product family: dbs-ipg-r-mri upn: (b)(4) model: db-1216 serial: (b)(6) batch: 505640 product family: dbs-lead fixation upn: (b)(4) model: db-4600c serial: n/a batch: 26809467.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient underwent a revision procedure to explant the entire dbs system due to lead erosion near the lead extension connector site.The explanted devices were sent for culture.No infection symptoms were noticed and the cause of the erosion is unknown.The patient was doing well post-operatively.Additional information was received that the cultures were negative for any infection and erosion was noticed while the patient was at the hairdresser three days prior to the explant procedure.
 
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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 Key18823047
MDR Text Key336738658
Report Number3006630150-2024-01137
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/22/2024
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? Yes
Device Operator Lay User/Patient
Device Expiration Date02/25/2023
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7080388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2024
Initial Date FDA Received03/01/2024
Supplement Dates Manufacturer Received03/28/2024
Supplement Dates FDA Received04/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2021
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 Age57 YR
Patient SexFemale
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