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

Model Number	DB-1140-S
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Battery Problem (2885)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation and noticed an increase in their parkinsons symptoms where they went from walking to wheelchair bound.Upon interrogation of the non-rechargeable implantable pulse generator (ipg) it was discovered that it had reached the end of service.The physician assessed that the event occurred when the patient had a non-device related surgery without turning off the ipg and he assessed that the electrocautery may have damaged the ipg.The patient underwent a revision procedure where the ipg was replaced.Postoperatively, the patient was doing well.
Additional Manufacturer Narrative
The end of service (eos) message was present on the returned ipg when it was linked to a remote control and clinical programmer.The ipg would not link to the software in order to obtain the data logs and performer a functional test, therefore the ipg was cut open and the internal electrical measurements were within the expected range.A labeling review was performed and it did not reveal any anomalies as it states that when the stimulator battery is fully depleted, eos indicator will be displayed on the remote control and clinician programmer.Stimulation will not be available.Surgery is required to replace the implanted non rechargeable stimulator to continue providing stimulation.Loss of adequate stimulation, worsening of disease symptoms, potentially caused by loss of stimulation, medication changes, surgery, or illness, and gait difficulty (trouble walking) and falls are known risks with the use of deep brain stimulation.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation and noticed an increase in their parkinsons symptoms where they went from walking to wheelchair bound.Upon interrogation of the non-rechargeable implantable pulse generator (ipg) it was discovered that it had reached the end of service.The physician assessed that the event occurred when the patient had a non-device related surgery without turning off the ipg and he assessed that the electrocautery may have damaged the ipg.The patient underwent a revision procedure where the ipg was replaced.Postoperatively, the patient was doing well.

• Brand Name: VERCISE PC
• Common Device Name: 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: 17774317
• Report Number: 3006630150-2023-05661
• Device Sequence Number: 7379247
• Product Code: NHL
• UDI-Device Identifier: 08714729984467
• UDI-Public: 08714729984467
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/26/2021
• Device Model Number: DB-1140-S
• Device Catalogue Number: DB-1140-S
• Device Lot Number: 631362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male