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 Problems Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 04/27/2020

Event Type  Injury  

Event Description

It was reported that the patient was not feeling well and his medication was adjusted as physician suspected it might have been reduced too much.Upon checking the dbs status, the physician assessed the system was turned off and the patient denied turning it off.The patient was later hospitalized and the dbs status was checked again and physician discovered the system to be turned off, and patient denied turning if off.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Event Description

It was reported that the patient was not feeling well and his medication was adjusted as physician suspected it might have been reduced too much.Upon checking the dbs status, the physician assessed the system was turned off and the patient denied turning it off.The patient was later hospitalized and the dbs status was checked again and physician discovered the system to be turned off, and patient denied turning if off.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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
• MDR Report Key: 10081208
• MDR Text Key: 191794991
• Report Number: 3006630150-2020-02163
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2021
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 740616
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization