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 Emotional Changes (1831); Headache (1880); Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 05/31/2022

Event Type  Injury  

Event Description

It was reported that the patient was implanted with a deep brain stimulation (dbs) system a few months ago, but experienced no clinical effects only side effects.The patient underwent an explant procedure to remove all implanted devices.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: unknown, batch: unknown ; product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: unknown, batch: unknown.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7074727.Product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: 7075139.

Event Description

It was reported that the patient was implanted with a deep brain stimulation (dbs) system a few months ago, but experienced no clinical effects only side effects.The patient underwent an explant procedure to remove all implanted devices.Additional information was received that the patient had symptoms of high emotionality and headaches due to the dbs leads being too deep.

Event Description

It was reported that the patient was implanted with a deep brain stimulation (dbs) system a few months ago, but experienced no clinical effects only side effects.The patient underwent an explant procedure to remove all implanted devices.Additional information was received that the patient had symptoms of high emotionality and headaches due to the dbs leads being too deep.The explanted devices were retained and discarded by the medical facility.The patient was fully recovered after the procedure.The patient was later implanted with a new dbs system two months later.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15069734
• MDR Text Key: 296287142
• Report Number: 3006630150-2022-03568
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

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 Expiration Date: 05/19/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 512443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 08/12/2022; 09/18/2022
• Supplement Dates FDA Received: 09/06/2022; 10/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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): Required Intervention