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

Model Number DB-1216

Device Problems Unexpected Therapeutic Results (1631); Intermittent Energy Output (4025)

Patient Problem Shaking/Tremors (2515)

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

B3: exact date unknown, event occurred approximately one month prior to the aware date.

Event Description

It was reported that the patient experienced a loss of stimulation and a return of bilateral upper extremity tremor while charging the deep brain stimulation (dbs) implantable pulse generator (ipg).However, when the charger was adjusted over the ipg, the symptoms resolved.The database analysis performed identified a bluetooth fault code when charging the ipg.Noise from the charging field for 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.No other anomalies were found with the analysis as the device displayed a normal charge log and all impedances were within expected range.A firmware update has been performed on the ipg, and the device remains implanted in the patient and delivering therapy.

Event Description

It was reported that the patient experienced a loss of stimulation and a return of bilateral upper extremity tremor while charging the deep brain stimulation (dbs) implantable pulse generator (ipg).However, when the charger was adjusted over the ipg, the symptoms resolved.The database analysis performed identified a bluetooth fault code when charging the ipg.Noise from the charging field for 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.No other anomalies were found with the analysis as the device displayed a normal charge log and all impedances were within expected range.A firmware update has been performed on the ipg, and the device remains implanted in the patient and delivering therapy.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: 18812124
• MDR Text Key: 336597178
• Report Number: 3006630150-2024-01085
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 544658
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: White