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

Model Number DB-1216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Movement Disorder (4412)

Event Date 03/16/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced pain and spasms following a deep brain stimulation (dbs) implantable pulse generator (ipg) procedure.The pain and spasms were likely result of the procedure that may have set off the patients dystonia per the physicians assessment.The physician prescribed post-operative medication and the patients stimulation settings were reviewed and will be monitored by their physician.Additional information has not provided despite good faith efforts.

Event Description

It was reported that the patient experienced pain and spasms following a deep brain stimulation (dbs) implantable pulse generator (ipg) procedure.The pain and spasms were likely result of the procedure that may have set off the patients dystonia per the physicians assessment.The physician prescribed post-operative medication and the patients stimulation settings were reviewed and will be monitored by their physician.Additional information has not provided despite good faith efforts.Additional information received that the worsening of symptoms was not device related however may be related the progression of their disease and will continue to be programmed in efforts to improve their symptoms per the physicians assessment.

• 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: 19076701
• MDR Text Key: 339773868
• Report Number: 3006630150-2024-02200
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 596663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2024
• 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; Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Race: White