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 Abscess (1690); Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a , batch: 32585850.Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a , batch: 32842642.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a wound infection in the right frontal cranial incision and a few spots of folliculitis near the implantable pulse generator (ipg) site.Keflex was provided to the patient.The investigator reports this adverse event was related to the device hardware and or procedure, not related to the device stimulation.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a wound infection in the right frontal cranial incision and a few spots of folliculitis near the implantable pulse generator (ipg) site.Keflex was provided to the patient.The investigator reports this adverse event was related to the device hardware and or procedure, not related to the device stimulation.Additional information was received indicating that the wound infection has now resolved.

• 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: 18987848
• MDR Text Key: 338726051
• Report Number: 3006630150-2024-01830
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 592795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• 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): Required Intervention