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

Model Number DB-1216

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

Exact date unknown, event occurred sometime between 09nov2023 and 16feb2024.

Event Description

It was reported the patient experienced discomfort and undesired sensations while charging their deep brain stimulation (dbs) system.A database analysis performed identified a bluetooth fault when charging the implantable pulse generator (ipg).Noise from the charging field of the charger interferes with the bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.The ipg remains implanted in the patient delivering therapy and charging with no additional issues.

Manufacturer Narrative

A field safety notice (fsn; 97178176-fa) was delivered to physicians in april 2024 communicating the potential for the vercise genus deep brain stimulation (dbs) implantable pulse generator (ipg) stimulation therapy to be transiently suspended during charging due to a device reset.The device reset behavior occurs in response to the detection of potential noise/interference during ipg charging.When the system resets, the patients programmed stimulation is suspended for approximately 10-15 seconds and then the device returns to normal operation once the reset is complete, including the delivery of stimulation therapy.In december 2023, a firmware update was implemented that will prevent this device reset behavior from occurring during ipg charging.

Event Description

It was reported the patient experienced discomfort and undesired sensations while charging their deep brain stimulation (dbs) system.A database analysis performed identified a bluetooth fault when charging the implantable pulse generator (ipg).Noise from the charging field of the charger interferes with the bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.The ipg remains implanted in the patient delivering therapy and charging with no additional issues.Additional information received indicates that a boston scientific representative performed an ipg firmware update that has resolved the bluetooth fault code error when charging the ipg.The applicable firmware is db-1216 version 9028506-102-00.The patient is able to successfully charge the ipg without interruption.No further action related to this event is needed.

• Brand Name: VERCISE GENUS
• 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: 19076594
• MDR Text Key: 339774333
• Report Number: 3006630150-2024-02197
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 565332
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2023
• 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 Age: 69 YR
• Patient Sex: Male