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

Model Number DB-2202-45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Headache (1880); Convulsion/Seizure (4406); Implant Pain (4561)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: (b)(4).Model: db-2202-45.Serial: (b)(4).Batch: 7074285.

Event Description

It was reported the patient had a non-device related fall, and subsequently experienced a lack of tremor control and complained of headaches.The patient experienced a sharp pain near the burr hole cover with the headache spreading throughout his body when laying on his back.He did not experience this issue in any other body position.Reprogramming attempts were unsuccessful with very little benefit to the patient's tremors.The patient was admitted to the hospital to run tests to help determine the cause of the reported events.A computerized tomography (ct) scan did not reveal any damage or issues with the implanted leads; however, the results of the electroencephalogram (eeg) revealed seizure activity.The patient was given seizure medication, and the physician assessed that the seizure activity was not related to the device, but may have been the source of the reported headaches.

Event Description

It was reported the patient had a non-device related fall, and subsequently experienced a lack of tremor control and complained of headaches.The patient experienced a sharp pain near the burr hole cover with the headache spreading throughout his body when laying on his back.He did not experience this issue in any other body position.Reprogramming attempts were unsuccessful with very little benefit to the patient's tremors.The patient was admitted to the hospital to run tests to help determine the cause of the reported events.A computerized tomography (ct) scan did not reveal any damage or issues with the implanted leads; however, the results of the electroencephalogram (eeg) revealed seizure activity.The patient was given seizure medication, and the physician assessed that the seizure activity was not related to the device, but may have been the source of the reported headaches.Additional information received that the patient underwent a revision procedure where the lead was replaced.The patient was stable post-operatively and no longer experienced the pain as before.The physician assessed that the cause of the headaches and pain were caused by undetectable lead damage.

Manufacturer Narrative

Device analysis performed on the returned db-2202-45 serial number (b)(6) revealed no anomalies.The lead passed functional testing and x-ray inspection, and exhibits normal characteristics.However, a labeling review found that pain at the implant site, headaches, and seizures are known risks of being implanted with the deep brain stimulation (dbs) system.The lead db-2202-45 serial number (b)(6) was not returned for analysis; therefore, physical investigation has not been conducted in our laboratory.However, a review of the manufacturing documentation for this device was performed and revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported the patient had a non-device related fall, and subsequently experienced a lack of tremor control and complained of headaches.The patient experienced a sharp pain near the burr hole cover with the headache spreading throughout his body when laying on his back.He did not experience this issue in any other body position.Reprogramming attempts were unsuccessful with very little benefit to the patient's tremors.The patient was admitted to the hospital to run tests to help determine the cause of the reported events.A computerized tomography (ct) scan did not reveal any damage or issues with the implanted leads; however, the results of the electroencephalogram (eeg) revealed seizure activity.The patient was given seizure medication, and the physician assessed that the seizure activity was not related to the device, but may have been the source of the reported headaches.Additional information received that the patient underwent a revision procedure where the lead was replaced.The patient was stable post-operatively and no longer experienced the pain as before.The physician assessed that the cause of the headaches and pain were caused by undetectable lead damage.

• 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 Key: 12207698
• MDR Text Key: 262870922
• Report Number: 3006630150-2021-03960
• 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: 12/16/2021

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 Date: 02/20/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7072722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 10/29/2021; 12/14/2021
• Supplement Dates FDA Received: 11/18/2021; 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male