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

Model Number DB-1200-S

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

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Shaking/Tremors (2515)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been analyzed, however analysis of the implantable pulse generator (ipg) database was performed.Bipolar and monopolar impedance measurements were observed to be within a normal range, and history counters revealed no issues with the ipg's functionality.Therefore, based on analysis of the ipg database information, engineers concluded the ipg is working as expected.

Event Description

It was reported the patient experienced shock-like sensations throughout his body while making adjustments to stimulation.Additionally, the patient experienced a gradual decrease in effective therapy which resulted in a return of his pre-implant tremors.Several attempts to reprogram the device were unsuccessful, and computed tomography (ct) imaging taken in the field confirmed proper device placement.The patient underwent a procedure where the implantable pulse generator (ipg) was replaced.The patient did well post-operatively and programmed successfully.

Event Description

It was reported the patient experienced shock-like sensations throughout his body while making adjustments to stimulation.Additionally, the patient experienced a gradual decrease in effective therapy which resulted in a return of his pre-implant tremors.Several attempts to reprogram the device were unsuccessful, and computed tomography (ct) imaging taken in the field confirmed proper device placement.The patient underwent a procedure where the implantable pulse generator (ipg) was replaced.The patient did well post-operatively and programmed successfully.

Manufacturer Narrative

Analysis of the returned implantable pulse generator (ipg) was analyzed and revealed no anomalies and exhibited normal device characteristics.Monitored stimulation on an oscilloscope found the outputs were consistent and correct on all electrodes.Analysis for current leakage and residual gas confirmed no loss of electric/stimulation current.However, a labeling review was conducted and the instructions for use (ifu) revealed loss of adequate stimulation and worsening of disease symptoms are known inherent risks associated with the use of deep brain stimulation.Correction to the initial mdr in block b3.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15423140
• MDR Text Key: 299925494
• Report Number: 3006630150-2022-04757
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• 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: 11/01/2022

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: 08/12/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 739709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2019
• 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: 61 YR
• Patient Sex: Male
• Patient Race: White