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

Model Number DB-1216

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330); Electric Shock (2554)

Event Date 09/24/2023

Event Type  malfunction  

Event Description

It was reported that the patient implanted with the referenced deep brain stimulation (dbs) implantable pulse generator (ipg) experienced shocking sensations and discomfort while charging the dbs ipg on several occasions.The device database analysis performed by a boston scientific technical support engineer noted communication faults occurred when the patient was charging the ipg.It was determined that the devices bluetooth low energy (ble) chip, which is used for communication, detected noise during charging of the ipg battery and the system reset.When a system reset occurs, the device stimulation momentarily turns off and then returns to normal operation.This sudden change in stimulation can result in a feeling of overstimulation.No other anomalies were found during the analysis as the device displayed a normal charge log and all impedance measurements were within expected range.The ipg remains implanted in the patient and delivering therapy.The investigation determined that the clinical observation of the patient feeling a shocking sensation during ipg charging was confirmed.Device data analysis noted communication faults when charging the ipg.It was determined that the devices bluetooth low energy (ble) chip, which is used for communication, detected noise during charging of the ipg battery and the system reset.When a system reset occurs, the device stimulation momentarily turns off and then returns to normal operation.This sudden change in stimulation can result in a feeling of overstimulation.As a result of this device behavior, the complaint has been confirmed.Boston scientifics investigation determined that this behavior is traced to design features of the device.

Event Description

It was reported that the patient implanted with the referenced deep brain stimulation (dbs) implantable pulse generator (ipg) experienced shocking sensations and discomfort while charging the dbs ipg on several occasions.The device database analysis performed by a boston scientific technical support engineer noted communication faults occurred when the patient was charging the ipg.It was determined that the devices bluetooth low energy (ble) chip, which is used for communication, detected noise during charging of the ipg battery and the system reset.When a system reset occurs, the device stimulation momentarily turns off and then returns to normal operation.This sudden change in stimulation can result in a feeling of overstimulation.No other anomalies were found during the analysis as the device displayed a normal charge log and all impedance measurements were within expected range.The ipg remains implanted in the patient and delivering therapy.The investigation determined that the clinical observation of the patient feeling a shocking sensation during ipg charging was confirmed.Device data analysis noted communication faults when charging the ipg.It was determined that the devices bluetooth low energy (ble) chip, which is used for communication, detected noise during charging of the ipg battery and the system reset.When a system reset occurs, the device stimulation momentarily turns off and then returns to normal operation.This sudden change in stimulation can result in a feeling of overstimulation.As a result of this device behavior, the complaint has been confirmed.Boston scientifics investigation determined that this behavior is traced to design features of the device.Additional information received indicated that the ipg firmware update was performed and has resolved the bluetooth fault code error when charging the ipg.The patient is able to successfully charge the ipg without interruption.No further action 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: 18337400
• MDR Text Key: 330834674
• Report Number: 3006630150-2023-07885
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: 561809
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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: 64 YR
• Patient Sex: Female