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

Model Number DB-1216

Device Problems Delayed Charge Time (2586); Charging Problem (2892)

Patient Problems Fall (1848); Implant Pain (4561)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred in (b)(6) 2022.

Event Description

It was reported that the patient experienced difficulty fully charging the implantable pulse generator (ipg) after a non-device related fall on the implant site.Troubleshooting and charging re-education was attempted which did not resolve the charging issue.Therefore, the patient underwent an ipg replacement procedure wherein the ipg was replaced with a non-rechargeable ipg.The patient is doing well postoperatively.

Event Description

It was reported that the patient experienced difficulty fully charging the implantable pulse generator (ipg) after a non-device related fall on the implant site.Troubleshooting and charging re-education was attempted which did not resolve the charging issue.Therefore, the patient underwent an ipg replacement procedure wherein the ipg was replaced with a non-rechargeable ipg.The patient is doing well postoperatively.

Manufacturer Narrative

Block b3: exact date unknown, event occurred in july 2022.Device analysis performed on the returned implantable pulse generator (ipg) revealed that it was able to be charged in one cycle and the battery depletion rate was within the expected range.Additionally, the ipg passed functional and electrical testing with no anomalies.However, the data log revealed that charging efficiency was greatly reduced at a specific timestamp therefore, it was concluded that the position of the ipg likely moved due to the patients fall.A review of the instructions for use (ifu) affirmed that suboptimal placement of the stimulator may result in an inability to recharge and implant site complications such as pain are known inherent risks with the use of spinal cord stimulation (scs).

• 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: 15491415
• MDR Text Key: 300635464
• Report Number: 3006630150-2022-05046
• 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: 11/08/2022

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: 11/09/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 526222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• 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: 63 YR
• Patient Sex: Female