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 Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported the patient experienced skin redness and itching in changing body regions shortly after being implanted with the deep brain stimulation (dbs) system.The physician assessed the patient had an allergic reaction to the implanted device based on the temporal connection.The patient was hospitalized and prescribed anti-histamine medication.

Manufacturer Narrative

Event date: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7091276.Product family: dbs-lead fixation; upn: m365db4600c0; model: db-4600c; serial: n/a; batch: 27845134.Product family: dbs-lead fixation; upn: m365db4600c0; model: db-4600c; serial: n/a; batch: 27889855.Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7091321.Product family: dbs-linear leads; upn: m365db2202300; model: db-2202-30; serial: (b)(4); batch: 7075765.Product family: dbs-linear leads; upn: m365db2202300; model: db-2202-30; serial: (b)(4); batch: 7075501.

• 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: 14836489
• MDR Text Key: 295047478
• Report Number: 3006630150-2022-03123
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2022

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: 10/18/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 524125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/27/2022
• 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): Required Intervention