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); Intermittent Energy Output (4025)

Patient Problems Undesired Nerve Stimulation (1980); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

The ipg was returned and passed all tests however failed the data log analysis.Device analysis confirmed a communication fault occurred while charging the ipg which can cause the system to reset, resulting in stimulation to turn off and back on.Therefore, the investigation conclusion of the patient experiencing shock like sensations while charging the ipg was confirmed.Therefore, the most probable cause is traced to device design.

Event Description

It was reported that the patient experienced shock like sensations while charging their deep brain stimulation (dbs) device, causing a brief return of her tremors.Analysis of the implantable pulse generator (ipg) data-logs revealed that it would only reset at random intervals while charging the ipg, causing the undesired stimulation.The issue did not resolve despite additional training, troubleshooting and the use of a new charging kit.Therefore, warranty authorization was provided to replace the ipg by boston scientific.The patient underwent a procedure where the ipg was replaced with another of the same model.The patient did well post-operatively.

• 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: 17840119
• MDR Text Key: 324550357
• Report Number: 3006630150-2023-05899
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2023

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: 09/22/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 523637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• 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: 63 YR
• Patient Sex: Female