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

Model Number DB-1216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/17/2023

Event Type  Injury  

Event Description

It was reported that while hospitalized for an unrelated cardiac procedure the patient fell and fractured their femur.The physician was unable to determine if the event was related to the device or stimulation, but noted the patient had a history of falls.Based on preliminary review of the patient programming report, stimulation may have been off for approximately two days; however, the specific times and dates the patient was without stimulation could not be determined based on this review.The patient underwent a procedure where an intramedullary nail was placed for fixation of the femur.Post-operatively the patient was moved to a facility for full-time care.

Event Description

It was reported that while hospitalized for an unrelated cardiac procedure the patient fell and fractured their femur.The physician was unable to determine if the event was related to the device or stimulation, but noted the patient had a history of falls.Based on preliminary review of the patient programming report, stimulation may have been off for approximately two days; however, the specific times and dates the patient was without stimulation could not be determined based on this review.The patient underwent a procedure where an intramedullary nail was placed for fixation of the femur.Post-operatively the patient was moved to a facility for full-time care.

Manufacturer Narrative

Analysis of the patient database download revealed history counters indicated there were thirty-six magnet resets and two hibernation events for the lifetime of the implantable pulse generator (ipg) having occurred in the month of (b)(6) 2023.The monopolar impedance measurements were observed to be within normal range.

• 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: 16359265
• MDR Text Key: 309366014
• Report Number: 3006630150-2023-00553
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/23/2023

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: 02/29/2024
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 535707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/11/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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): Hospitalization; Required Intervention