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

Model Number DB-1416

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Discomfort (2330); Shaking/Tremors (2515); Movement Disorder (4412)

Event Date 02/08/2024

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient was admitted to the hospital due to loss of therapy.The patients parkinsons disease symptoms started to reemerge and patient experienced discomfort and pain.

Event Description

It was reported that the deep brain stimulation (dbs) patient was admitted to the hospital due to loss of therapy.The patients parkinsons disease symptoms started to reemerge and patient experienced discomfort and pain.A database analysis was completed but inconclusive as there had been numerous program changes in the last 28 days and the stimulation had been left off for 5 days.

Event Description

It was reported that the deep brain stimulation (dbs) patient was admitted to the hospital due to loss of therapy.The patients parkinsons disease symptoms started to reemerge and patient experienced discomfort and pain.A database analysis was completed but inconclusive as there had been numerous program changes in the last 28 days and the stimulation had been left off for 5 days.Additional information was received that the patients medication was increased to the level before the dbs implantation.

• 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: 18754354
• MDR Text Key: 335933538
• Report Number: 3006630150-2024-00870
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985020
• UDI-Public: 08714729985020
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 212560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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