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

Model Number DB-1416

Device Problems Unexpected Therapeutic Results (1631); Battery Problem (2885); Wireless Communication Problem (3283)

Patient Problem Shaking/Tremors (2515)

Event Date 11/28/2022

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced loss of stimulation and the return of the patient's parkinson's disease symptoms.The patient had difficulty communicating with the implantable pulse generator (ipg) and the ipg had entered the end of service mode.The patient underwent an ipg replacement procedure.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced loss of stimulation and the return of the patient's parkinson's disease symptoms.The patient had difficulty communicating with the implantable pulse generator (ipg) and the ipg had entered the end of service mode.The patient underwent an ipg replacement procedure.Additional information was received that the ipg had not entered the end of service mode and the patient did not undergo an ipg replacement procedure.The patients care team attempted to use an old remote to try and communicate with the ipg.When the correct remote control was used, therapy and communication resumed.As there was no reported allegation against the device itself and no indication of an issue with device performance, boston scientific no longer considers this to be a reportable event.

• 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: 16043583
• MDR Text Key: 306093905
• Report Number: 3006630150-2022-07211
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985020
• UDI-Public: 08714729985020
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/06/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2024
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 207976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 01/08/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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