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

Model Number DB-1408

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

Patient Problems Fluid Discharge (2686); Convulsion/Seizure (4406)

Event Date 02/24/2024

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a seizure on (b)(6) 2024 and presented to the emergency room (er).On (b)(6) 2024, the patient was admitted to the er for a fall.The dbs system was confirmed to be off, and impedances were normal.The left lead incision site appeared to be leaking clear fluid and some blood.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a seizure on (b)(6) 2024 and presented to the emergency room (er).On (b)(6)2024, the patient was admitted to the er for a fall.The dbs system was confirmed to be off, and impedances were normal.The left lead incision site appeared to be leaking clear fluid and some blood.Additional information was received indicated that the patient had a continuous positive airway pressure (cpap) machine that would sit on the incision site and the patient had been picking at the site which likely led to the leaking clear fluid and some blood.

• 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: 18882545
• MDR Text Key: 337411161
• Report Number: 3006630150-2024-01373
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729989752
• UDI-Public: 08714729989752
• 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: 04/03/2024

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-1408
• Device Catalogue Number: DB-1408
• Device Lot Number: 220256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Male