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

Model Number	DB-1140-S
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient underwent a revision procedure to replace the implantable pulse generator (ipg) due to premature battery depletion.
Additional Manufacturer Narrative
The ipg db-1140-s serial number (b)(6) was returned and analyzed.The event of the ipg only lasting 22 months and requiring a replacement procedure was confirmed through laboratory analysis, which revealed that the ipg could be linked with an rc (remote control), but it could not be linked with the troubleshooting tool in the lab.The device was cut open and the battery measured 2.41 volts.Attempts to bring up the device from the eos (end of service) state using an external power source were not successful.The pcb (printed circuit board) level electrical test revealed normal device characteristics.Since the device is no longer responding, the ipg logs could not be retrieved to be able to calculate the battery longevity.It is possible that the ipg was damaged during the explant procedure due to an unknown source.No anomalies were identified that could have contributed in high impedances.The ipg passed visual, x-ray, and borescope inspection.However, review of clinician programmer session reports supports that an intermittent open circuit was included in programming configuration for 313 days.Per ipg design, high impedance electrodes that are included in programming configuration are expected to recruit more battery.The energy use index (eui) does not adaptively calculate remaining ipg life and eui does not account for high impedance electrodes included in programming.The device was in service for 655 days.The possible damage to the associated lead could have contributed to the open/high impedance electrodes.The use of intermittent open contacts/electrodes resulted in the premature battery depletion of the ipg.
Event or Problem Description
It was reported the patient underwent a revision procedure to replace the implantable pulse generator (ipg) due to premature battery depletion.The procedure was completed successfully.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12637290
• Report Number: 3006630150-2021-05775
• Device Sequence Number: 11072732
• Product Code: NHL
• UDI-Device Identifier: 08714729984467
• UDI-Public: 08714729984467
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/13/2020
• Device Model Number: DB-1140-S
• Device Catalogue Number: DB-1140-S
• Device Lot Number: 631161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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: 64 YR
• Patient Sex: Male