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 Depression (2361); Convulsion/Seizure (4406)

Event Date 12/08/2022

Event Type  Injury  

Event Description

It was reported that the clinical study patient experienced an epileptic seizure, which was assessed as being mild in severity.The event was resolved.The physician assessed the event as having a possible relationship to the procedure, but the relationship to the device was reported as not related.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(4), batch: 7076176.Product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(4), batch: 7076980.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: (b)(6).Product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: (b)(6).

Event Description

It was reported that the clinical study patient experienced an epileptic seizure, which was assessed as being mild in severity.The event was resolved.The physician assessed the event as having a possible relationship to the procedure, but the relationship to the device was reported as not related.Additional information was received that complications such as a bleed or fresh ischemia, cerebrospinal fluid circulation disorder, and signs of herniation were excluded through a cranial computed tomography (ct) scan and chest x-ray.The deep brain stimulation (dbs) system was also in regular position.An additional therapy with levetiracetam was initiated to treat the patient.No new abnormalities in the sense of an epileptic event were recorded over the short-term course of inpatient treatment.The lab tests revealed a valproic acid level below the therapeutic limit, for which reason the patients dose of medication was increased.The physician deescalated levetiracetam with the goal of establishing monotherapy again over time.Due to the patients reported depressed mood due to the disease and the mood-stabilizing effect of valproic acid, the physician did not recommend discontinuing or substituting the patients medication at this time.

• 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: 16278923
• MDR Text Key: 308566775
• Report Number: 3006630150-2023-00324
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

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 Expiration Date: 10/18/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 525647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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): Other
• Patient Sex: Male