MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-2202-45

Device Problems Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problem Pain (1994)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event product family, upn m365db4600c0, model db-4600-c, lot-batch 30042540.

Event Description

It was reported that the patient was receiving ineffective therapy from their deep brain stimulation (dbs) system.A computed tomography (ct) scan was ordered to verify the lead position.After review of the scan it was discovered that the lead was short of target, which was the ventral intermediate (vim) nucleus of the thalamus.On the day the lead was originally placed, the postoperative scan confirmed that the lead was on target.Since the new ct showed the lead was shallow, the neurosurgeon decided to look at a postoperative x-ray that was taken 2 hours following the battery placement procedure and believes the lead looked shallow in that image.Therefore, they suspect the depth of the lead changed at some point following the first post op ct following the lead placement.The patient underwent a revision procedure in which the surgeon observed that the locking clip from the burr hole cover that is intended to secure the lead, was not secured.The physician replaced the lead and the burr hole cover.There were no patient complications, and the procedure was completed successfully.The lead will not be returned as it was discarded at the medical facility.

Event Description

It was reported that the patient was receiving ineffective therapy from their deep brain stimulation (dbs) system.A computed tomography (ct) scan was ordered to verify the lead position.After review of the scan it was discovered that the lead was short of target, which was the ventral intermediate (vim) nucleus of the thalamus.On the day the lead was originally placed, the postoperative scan confirmed that the lead was on target.Since the new ct showed the lead was shallow, the neurosurgeon decided to look at a postoperative x-ray that was taken 2 hours following the battery placement procedure and believes the lead looked shallow in that image.Therefore, they suspect the depth of the lead changed at some point following the first post op ct following the lead placement.The patient underwent a revision procedure in which the surgeon observed that the locking clip from the burr hole cover that is intended to secure the lead, was not secured.The physician replaced the lead and the burr hole cover.There were no patient complications, and the procedure was completed successfully.The lead will not be returned as it was discarded at the medical facility.

Manufacturer Narrative

Lead db-2202-45, serial (b)(6) was not returned for analysis as it was retained by the medical facility.As such, a physical analysis has not been conducted in our laboratory.A product labeling review identified that the lead was used per the instructions for use (ifu) product label.The ifu states that 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, loss of adequate stimulation and pain, headache or discomfort are known risks with the use of deep brain stimulation.The returned burr hole cover locking clip db-4600-c, lot 30042540 was analyzed and the event was confirmed.The burr hole cover retaining clip passed the visual inspection and a known good lead was successfully attached; however, there was some difficulty with the lead clip assembly locking mechanism when securing the lead to the burr hole cover.

Manufacturer Narrative

Lead db-2202-45, serial (b)(6) was not returned for analysis as it was retained by the medical facility.As such, a physical analysis has not been conducted in our laboratory.A product labeling review identified that the lead was used per the instructions for use (ifu) product label.The ifu states that 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, loss of adequate stimulation and pain, headache or discomfort are known risks with the use of deep brain stimulation.The returned burr hole cover locking clip db-4600-c lot 30042540 was analyzed and the event was confirmed.The burr hole cover retaining clip passed the visual inspection and a known good lead was successfully attached; however, there was some difficulty with the lead clip assembly locking mechanism when securing the lead to the burr hole cover.

Event Description

It was reported that the patient was receiving ineffective therapy from their deep brain stimulation (dbs) system.A computed tomography (ct) scan was ordered to verify the lead position.After review of the scan it was discovered that the lead was short of target, which was the ventral intermediate (vim) nucleus of the thalamus.On the day the lead was originally placed, the postoperative scan confirmed that the lead was on target.Since the new ct showed the lead was shallow, the neurosurgeon decided to look at a postoperative x-ray that was taken 2 hours following the battery placement procedure and believes the lead looked shallow in that image.Therefore, they suspect the depth of the lead changed at some point following the first post op ct following the lead placement.The patient underwent a revision procedure in which the surgeon observed that the locking clip from the burr hole cover that is intended to secure the lead, was not secured.The physician replaced the lead and the burr hole cover.There were no patient complications, and the procedure was completed successfully.The lead will not be returned as it was discarded at the medical facility.Additional information was received that it is believed that the clip was not locked on one side from the initial implant on (b)(6) 2022.

• 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 Key: 18111055
• MDR Text Key: 327880938
• Report Number: 3006630150-2023-06924
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• 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: 04/30/2024

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 Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7095996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 02/01/2024; 04/29/2024
• Supplement Dates FDA Received: 02/21/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female