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

Model Number DB-1216

Device Problems Charging Problem (2892); Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

Event Type  Injury  

Event Description

It was reported that following a previously reported revision procedure it was discovered that communication with the patients' implantable pulse generator (ipg) of the deep brain stimulation (dbs) system could not be established.A communication error was received on the clinician programmer, a magnet reset was attempted, and a second clinician programmer was utilized but did not resolve the communication issue.The patient underwent a procedure in which the ipg was explanted and is doing well post operatively.

Manufacturer Narrative

The ipg was returned and analyzed, it would not charge despite multiple charging attempts, and communication could not be established with a known good remote control (rc) or clinician programmer (cp).Therefore, the data logs could not be retrieved or analyzed, and no functional testing could be performed.The ipg was then cut open, and internal electrical measurements revealed excessive sleep current and low resistance of a node where high resistance was expected, which confirms that the application-specific integrated circuit (asic) chip is damaged.This damage is typically caused by the ipg exposure to external high voltage/high current transient sources.A labeling review was performed on the devices' instructions for use, ifu and it states that the following medical therapies or procedures may turn stimulation off, cause permanent damage to the stimulator.If any of these procedures are required by medical necessity: electrocautery, external defibrillation, ultrasonic scanning, lithotripsy, radiation therapy, transcranial stimulation.The procedures should be performed as far from the implanted components as possible.X-ray and ct scans may damage the stimulator if stimulation is on.X-ray and ct scans are unlikely to damage the stimulator if stimulation is turned off.Stimulator function should be confirmed after the procedure.Ultimately, however, the stimulator may require explantation because of damage to the device.Based on all available information, engineers are able to confirm the root cause of the event.The ipg was returned and analyzed, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint and the conclusion is unintended use error caused or contributed to event.

Event Description

It was reported that following a previously reported revision procedure it was discovered that communication with the patients' implantable pulse generator (ipg) of the deep brain stimulation (dbs) system could not be established.A communication error was received on the clinician programmer, a magnet reset was attempted, and a second clinician programmer was utilized but did not resolve the communication issue.The patient underwent a procedure in which the ipg was explanted and is doing 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: 18426601
• MDR Text Key: 331863258
• Report Number: 3006630150-2023-08280
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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: 556418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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