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

Model Number DB-1200

Device Problems Unexpected Therapeutic Results (1631); Defective Device (2588)

Patient Problem Dyskinesia (2363)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that the during a follow up visit the patient experienced a return of their symptoms of dyskinesia.Reprogramming was attempted and resolved the symptoms.However, on the following day the patients symptoms returned and continued for a week.During the next follow up visit reprogramming was attempted again but the symptoms did not resolve.The physician suspected that there may be a possible device malfunction.Device analysis has been completed and the device is working as expected.The patient has been hospitalized, and it is unclear if any medical or surgical intervention has been provided.

Manufacturer Narrative

Correction to field b5: describe event or problem.

Event Description

It was reported that the during a follow up visit the patient experienced a return of their symptoms of dyskinesia.Reprogramming was attempted and resolved the symptoms.However, on the following day the patient's symptoms returned and continued for a week.During the next follow up visit reprogramming was attempted again but the symptoms did not resolve.The physician suspected that there may be a possible device malfunction.Database analysis has been completed and the device is working as expected.The patient has been hospitalized, and it is unclear if any medical or surgical intervention has been provided.Additional information was received that the patient's symptoms subsided after the stimulation was adjusted and oral medication was given during the hospitalization.

• 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: 12889217
• MDR Text Key: 281392323
• Report Number: 3006630150-2021-06813
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/11/2021
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 737540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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): Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Female