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

Model Number DB-1216

Device Problems Device Displays Incorrect Message (2591); Wireless Communication Problem (3283)

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

Event Date 05/19/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent an explant procedure due to communication difficulty with the implantable pulse generator (ipg).

Event Description

It was reported that the patient underwent an explant procedure due to communication difficulty with the implantable pulse generator (ipg).

Manufacturer Narrative

Analysis of the returned ipg revealed that the device could not be detected by a remote control after several charging attempts.An internal inspection found a completely depleted internal battery and excessive quiescent current leak.High voltage (vh) node to ground impedance also measured low suggesting that the device was damaged by high-voltage transients or high radio frequency(rf) energy, resulting in electrical shorts within the application-specific integrated circuit (asic).The electrical short in the asic caused the inability to communicate with the ipg battery.The cause of the asic damage is unknown.A product labeling review identified that the device was used per the instructions for use (ifu) product label.The instructions for use (ifu) cautions that the following medical therapies or procedures may turn the stimulation off, cause permanent damage to the stimulator or may cause injury to the patient: electrocautery, external defibrillation, diagnostic ultrasonic scanning, lithotripsy, radiation therapy, transcranial stimulation, x-ray and computed tomography scans.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14568471
• MDR Text Key: 293117650
• Report Number: 3006630150-2022-02637
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P150031
• 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: 08/16/2022

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: 03/15/2024
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 535191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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