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 Bacterial Infection (1735); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 06/02/2023

Event Type  Injury  

Event Description

It was reported that the patients spinal cord stimulator implantable pulse generator (ipg) site was red, warm to the touch, and painful, therefore, the patient was prescribed antibiotics.The patient was doing well and the ipg site had improved; however, the patient was admitted to the hospital and underwent a procedure where the ipg site was opened to irrigate and debride.It was then found that the anchor stitch was no longer attached.The ipg was re-sutured in position and left in situ.There were no reported issues postoperatively.The physician assessed that the patient had done too many stretches and neck movements resulting in the symptoms and confirmed there was no infection.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: (b)(6).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), lot: (b)(6).

Event Description

It was reported that the patients spinal cord stimulator implantable pulse generator (ipg) site was red, warm to the touch, and painful, therefore, the patient was prescribed antibiotics.The patient was doing well and the ipg site had improved; however, the patient was admitted to the hospital and underwent a procedure where the ipg site was opened to irrigate and debride.It was then found that the anchor stitch was no longer attached.The ipg was re-sutured in position and left in situ.There were no reported issues postoperatively.The physician assessed that the patient had done too many stretches and neck movements resulting in the symptoms and confirmed there was no infection.Additional information was received that the patient pocket site pain and tenderness in the chest returned due to an infection.The patient underwent a procedure where the ipg and lead extensions were explanted.The patient was sent home with antibiotics and was doing well.The cause of the infection was unable to be determined, however, it was not thought to be device related.The devices were not returned as they were retained by the medical facility.

• 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: 17183285
• MDR Text Key: 317669905
• Report Number: 3006630150-2023-03599
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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: 563623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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; Hospitalization
• Patient Sex: Male