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 Inflammation (1932); Swelling/ Edema (4577)

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced inflammation and edema at the site of the implantable pulse generator (ipg) pocket site.The patient was admitted to the hospital where they underwent a revision procedure where the ipg was explanted.The patient was doing well post operatively and was released on the same day.Additional information was received indicating that the implantable pulse generator (ipg) was not explanted.The patient underwent an exploratory surgery where the physician examined the ipg site and performed surgical cleaning and removed some sutures.The physician would continue to observe the site to ensure successful healing.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced inflammation and edema at the site of the implantable pulse generator (ipg) pocket site.The patient was admitted to the hospital where they underwent a revision procedure where the ipg was explanted.The patient was doing well post operatively and was released on the same day.Additional information was received indicating that the implantable pulse generator (ipg) was not explanted.The patient underwent an exploratory surgery where the physician examined the ipg site and performed surgical cleaning and removed some sutures.The physician would continue to observe the site to ensure successful healing.Additional information was received indicating that the deep brain stimulation (dbs) patient underwent a revision procedure where the implantable pulse generator (ipg) was explanted.The patient was doing well post-operatively.The explanted device was discarded by the hospital.

• 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: 18849758
• MDR Text Key: 337037444
• Report Number: 3006630150-2024-01246
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P150031
• 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
• Report Date: 03/29/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 568704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male