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 Arrhythmia (1721); Dyspnea (1816); High Blood Pressure/ Hypertension (1908)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550 , model: nm-3138-55, serial: (b)(4), batch: 7084237.Product family: dbs-extension, upn: m365nm3138550 , model: nm-3138-55, serial: (b)(4), batch: 7085390.Product family: dbs-lead fixation, upn: m365db4600c0 , model: db-4600c, serial: n/a, batch: 26729878.Product family: dbs-lead fixation, upn: m365db4600c0 , model: db-4600c, serial: n/a, batch: 26793896.Product family: dbs-lead fixation, upn: m365db4605c0, model: db-4605c, serial: n/a, batch: 26515106.Product family: dbs-linear leads, upn: m365db2202450 , model: db-2202-45, serial: (b)(4), batch: 7080528.Product family: dbs-linear leads, upn: m365db2202450 , model: db-2202-45, serial: (b)(4), batch: 7080583.

Event Description

It was reported that the patient experienced difficulty breathing and a fluctuation in her blood pressure and heart rate.The patient underwent an explant procedure of the deep brain stimulation system.

Event Description

It was reported that the patient experienced difficulty breathing and a fluctuation in her blood pressure and heart rate.The patient underwent an explant procedure of the deep brain stimulation system.Additional information was received that the physician assessed he does not think this issue was device related.

Manufacturer Narrative

Db-1216, (b)(6) the returned ipg passed the visual inspection and revealed no anomalies.Db-2202-45, (b)(6) visual inspection revealed that the lead was cleanly cut into two pieces from the distal end of the lead.The clean cut damage is a result of a typical explant procedure, and it is not considered a failure.No other anomalies were identified on the returned portion of the lead.

Event Description

It was reported that the patient experienced difficulty breathing and a fluctuation in her blood pressure and heart rate.The patient underwent an explant procedure of the deep brain stimulation system.Additional information was received that the physician assessed he does not think this issue was device related.

• 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: 13972437
• MDR Text Key: 288352277
• Report Number: 3006630150-2022-01373
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/13/2024

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 Expiration Date: 03/12/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 506347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/07/2022; 02/21/2024
• Supplement Dates FDA Received: 04/29/2022; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female