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

Model Number DB-1200

Device Problem Intermittent Energy Output (4025)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/15/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent and implantable pulse generator (ipg) revision procedure.The patient was experiencing inadequate stimulation caused by the ipg turning off unexpectedly.

Event Description

It was reported that the patient underwent and implantable pulse generator (ipg) revision procedure.The patient was experiencing inadequate stimulation caused by the ipg turning off unexpectedly.

Manufacturer Narrative

Investigation summary: with the available information, boston scientific concludes that the reported observations associated with intermittent stimulation caused by the ipg was not able to be confirmed following device analysis.Upon receiving the ipg the system reset count was 365 and following one month the reset count increased to 367 after the functional test.It was confirmed that no stimulation interruption had occurred due to the ipg malfunction prior to the device being returned.Monitored stimulation on an oscilloscope found the outputs were consistent and correct on all electrodes.The ipg passed the functional test, and engineers determined that the electrical test revealed normal device characteristics.Investigation conclusion: review of the device's manufacturing documentation confirmed that this ipg passed all required specifications and testing prior to being released for distribution/sale.It was reported that the patient was experiencing inadequate stimulation caused by the ipg turning off unexpectedly.Based on the results of the laboratory testing and available information, engineers concluded that the returned device did not identify any product performance-related issues.Laboratory analysis of the returned device did not reveal any anomalies or problems with the device.

• Brand Name: VERCISE GEVIA
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12845703
• MDR Text Key: 281032658
• Report Number: 3006630150-2021-06574
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2021
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 739016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• 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 Sex: Male