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

Model Number DB-1110-C

Device Problems Unexpected Therapeutic Results (1631); Device Displays Incorrect Message (2591); Wireless Communication Problem (3283)

Patient Problem Shaking/Tremors (2515)

Event Date 01/28/2023

Event Type  Injury  

Event Description

It was reported the patient experienced a loss of stimulation and a return of their tremors.Upon attempting to turn stimulation back on, the remote control displayed an error message and communication between the remote and implantable pulse generator (ipg) could not be established.Various troubleshooting steps were unsuccessfully executed; however, performing a magnet reset resolved the communication issue, as such, stimulation was turned on and tremors were controlled.However, the patient continued to experience occasional losses of stimulation with persisting remote error messages and communication difficulty.Analysis of the ipg database download and patient data logs revealed no anomalies and engineers were unable to determine the cause of the event.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.

Manufacturer Narrative

Analysis of the returned ipg revealed no anomalies.The device passed the functional test and exhibited normal device characteristics.The reported error code did not occur during analysis, and communication was established with ipg.A review of the data logs revealed the battery voltage did not drop below 2.7 volts where a reset would occur, and stimulation would turn off.Additionally, the device did not abnormally reset during the analysis of the ipg.

Event Description

It was reported the patient experienced a loss of stimulation and a return of their tremors.Upon attempting to turn stimulation back on, the remote control displayed an error message and communication between the remote and implantable pulse generator (ipg) could not be established.Various troubleshooting steps were unsuccessfully executed; however, performing a magnet reset resolved the communication issue, as such, stimulation was turned on and tremors were controlled.However, the patient continued to experience occasional loss of stimulation with persisting remote error messages and communication difficulty.Analysis of the ipg database download and patient data logs revealed no anomalies and engineers were unable to determine the cause of the event.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.

• Brand Name: VERCISE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16838494
• MDR Text Key: 314259703
• Report Number: 3006630150-2023-02377
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/07/2020
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 21606576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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