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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 Problems Unexpected Therapeutic Results (1631); Failure to Disconnect (2541); Migration (4003)
Patient Problems Fall (1848); Inadequate Pain Relief (2388)
Event Date 04/05/2022
Event Type  Injury  
Event Description
It was reported that the patient experienced a fall and the leads migrated.The cause of the fall is unknown.The patient experienced inadequate stimulation and underwent a lead revision procedure where the leads were replaced.During the procedure, one lead was unable to be removed from the lead extension, therefore, the lead extension was also replaced.The patient is doing well postoperatively.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(4).Lot: 7084508.Product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(4).Lot: 7093650.
 
Event Description
It was reported that the patient experienced a fall and the leads migrated.The cause of the fall is unknown.The patient experienced inadequate stimulation and underwent a lead revision procedure where the leads were replaced.During the procedure, one lead was unable to be removed from the lead extension, therefore, the lead extension was also replaced.The patient is doing well postoperatively.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), lot: (b)(4).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55 , serial: (b)(4), lot: (b)(4).Lead db-2202-45 sn (b)(6) was not returned as the device was disposed of by the medical facility.As such, physical analysis has not been conducted in our laboratory.The returned lead db-2202-45 sn (b)(6) was analyzed and revealed that the proximal end of the lead was torn after contact 7.Contact 8 was stuck in the associated lead extension and the retention sleeve was not returned.Cables are exposed at the fracture site.It appears that excessive mechanical force was exerted onto the lead during the attempt to remove it from the lead extension and it resulted in the complete separation of the proximal end from the lead body.Visual inspection of proximal array contacts 6, 7, and 8 were deformed.It is likely that they were damaged by a surgical tool during the implant procedure.The contact deformation resulted in the inability to remove the lead from the lead extension connector.The returned lead extension nm-3138-55 sn (b)(6) was analyzed and revealed that the associated lead was stuck in the lead extension connector.It was found that the associated leads proximal contacts were deformed.The contact deformation resulted in the inability to remove the lead from the lead extension connector.A labelling review was performed did not reveal any anomalies.The labeling, instructions for use (ifu) states that device related risks can include loss of adequate stimulation and implanted device components (stimulator, lead, or extension) may move from original implanted location or wear through the skin, which may lead to the need for additional surgery.Possible side-effects of stimulation can include gait difficulty and falls.Therefore, falls and lead migration are known risks with use of the products.Furthermore, labeling states to take care not to bend or kink the proximal lead array, the stiff portion of the lead body adjacent to the array, or the lead extension connector during insertion.
 
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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
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key14246151
MDR Text Key290412387
Report Number3006630150-2022-01898
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 06/21/2022
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 Date07/20/2023
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7084504
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2022
Initial Date FDA Received04/28/2022
Supplement Dates Manufacturer Received05/31/2022
Supplement Dates FDA Received06/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2021
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 Age59 YR
Patient SexMale
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