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

Model Number DB-1216

Device Problem Use of Device Problem (1670)

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

Event Date 09/11/2023

Event Type  Injury  

Event Description

It was reported that during the deep brain stimulation (dbs) procedure to implant the leads that the implantable pulse generator (ipg) was damaged due to the physician's use of plasma blade cautery.The damaged ipg was replaced.The patient was doing well post-operatively.

Manufacturer Narrative

The returned ipg was analyzed and revealed that the device would not charge despite multiple attempts, and the internal electrical measurements confirmed an excessive sleep current and a low impedance measurement.The application specific integrated circuit asic chip was damaged.This type of damage is typically caused by the ipg exposure to high voltage or high current transients.The excessive current drawn from the damaged asic was caused utilizing plasma blade cautery and was an unintended use error that caused or contributed to the event.A product labeling review was conducted.This review determined that the following medical therapies or procedures may turn stimulation off, cause permanent damage to the stimulator, or may cause injury to the patient.If any of the procedures below is required by medical necessity, the procedures should be performed as far from the implanted components as possible.Stimulator function should be confirmed after the procedure.Ultimately, however, the stimulator may require explantation because of damage to the device or patient harm.Electrocautery can transfer destructive current into the dbs leads and or stimulator.Bipolar or monopolar electrocautery may be used.Electrocautery probes must be kept a minimum of 1 inch away from the implanted device.

Event Description

It was reported that during the deep brain stimulation (dbs) procedure to implant the leads that the implantable pulse generator (ipg) was damaged due to the physician's use of plasma blade cautery.The damaged ipg was replaced.The patient was 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: 17887369
• MDR Text Key: 325123865
• Report Number: 3006630150-2023-06082
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 572721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• 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: 67 YR
• Patient Sex: Male