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 Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 02/03/2024

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a rash and inflammation around the implantable pulse generator (ipg) pocket site approximately five days after the implant procedure.The patient was admitted to the hospital, where the physician assessed the event to likely be caused by the tape and gauze that was placed around the incision site, as no infection was observed.The patient was prescribed a corticosteroid cream and was observed by dermatology.The issue has since 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: 18812534
• MDR Text Key: 336619899
• Report Number: 3006630150-2024-01086
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

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 Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 595063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2024
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male