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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); Erosion (1750)
Event Date 11/22/2022
Event Type  Injury  
Event Description
It was reported that the patient experienced an infection at the right lead site, with erosion of the skin.The physician stated the infection was not device related.The patient underwent an explant of the right lead and right lead extension, was placed on antibiotics, and is doing well post operatively.Cultures were taken but the results are unknown.The devices will not be returned for analysis as they were disposed of by the facility.It is unclear as to which of the two leads is the explanted lead.
 
Manufacturer Narrative
Date of event: 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)(4), batch: 7086662; product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7091975.
 
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: (b)(6).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: (b)(6).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 27571242.
 
Event Description
It was reported that the patient experienced an infection at the right lead site, with erosion of the skin.The physician stated the infection was not device related.The patient underwent an explant of the right lead and right lead extension, was placed on antibiotics, and is doing well post operatively.Cultures were taken but the results are unknown.The devices will not be returned for analysis as they were disposed of by the facility.It is unclear as to which of the two leads is the explanted lead.It was additionally reported that the burr hole cover was also explanted during the explant procedure.
 
Event Description
It was reported that the patient experienced an infection at the right lead site, with erosion of the skin.The physician stated the infection was not device related.The patient underwent an explant of the right lead and right lead extension, was placed on antibiotics, and is doing well post operatively.Cultures were taken but the results are unknown.The devices will not be returned for analysis as they were disposed of by the facility.It is unclear as to which of the two leads is the explanted lead.It was additionally reported that the burr hole cover was also explanted during the explant procedure.Information was received that the patient had a second lead extension and it is unclear which of the two lead extensions was explanted.
 
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: 7086662; product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7091975 and 7094616; product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, batch: 27571242.
 
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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 Key15998692
MDR Text Key305640841
Report Number3006630150-2022-07055
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,Followup
Report Date 07/10/2023
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 Expiration Date07/16/2023
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7084367
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2022
Initial Date FDA Received12/16/2022
Supplement Dates Manufacturer Received01/06/2023
06/12/2023
Supplement Dates FDA Received01/31/2023
07/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2021
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 Age70 YR
Patient SexMale
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