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

Model Number DB-1200-S

Device Problem Intermittent Energy Output (4025)

Patient Problems Undesired Nerve Stimulation (1980); Paresthesia (4421)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced random tingling and electrical sensations throughout his body for several months.It was noted that the sensation did not occur during charging, programming, using the remote control or while the patient changed positions.The patient underwent a revision procedure in which the deep brain stimulation (dbs) implantable pulse generator (ipg) was replaced.The patient is doing well post operatively.

Manufacturer Narrative

The ipg exhibited normal device characteristics during the visual examination.However, while attempting to obtain the data logs and perform the ate functional test, an unexpected software error occurred.Although the ipg could connect to a known good remote control (rc) and clinical programmer (cp) without any issues.The output signal was monitored for 24 hours with stimulation on and confirmed that the stimulation stayed on all the time, and the current leakage test verified that there was no loss of electric current, and the residual gas analysis confirmed that the case was intact.A labeling review was performed on devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states failure or malfunction of any part of the device, including but not limited to battery leakage, battery failure, lead or extension breakage, hardware malfunctions, loose connections, electrical shorts or open circuits, and lead insulation breaches, whether or not these problems require device removal and/or replacement, loss of adequate stimulation and undesirable sensations (e.G., tingling) are a known risks with the use of deep brain stimulation.Based on all available information, engineers are able to confirm the root cause of the event.The ipg was returned and analyzed, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint and the conclusion is known inherent risk of device.

Event Description

It was reported that the patient experienced random tingling and electrical sensations throughout his body for several months.It was noted that the sensation did not occur during charging, programming, using the remote control or while the patient changed positions.The patient underwent a revision procedure in which the deep brain stimulation (dbs) implantable pulse generator (ipg) was replaced.The patient is doing well post operatively.

• Brand Name: VERCISE GEVIA
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17804388
• MDR Text Key: 324107398
• Report Number: 3006630150-2023-05789
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/02/2024

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 Date: 03/12/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 742506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male