MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number DB-1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Impaired Healing (2378)

Event Date 01/04/2022

Event Type  Injury  

Event Description

It was reported that the patient had a wound healing issue at the implantable pulse generator site which was severe.The patient was hospitalized and administered medication.The event was assessed to be causally related to the device and procedure, and not device related.The device remains implanted and the event has resolved.

Event Description

It was reported that the patient had a wound healing issue at the implantable pulse generator site area which was severe.The patient was hospitalized and administered medication.The event was assessed to be causally related to the device and procedure, and not device related.The device remains implanted and the event has resolved.Additional information was received that the event was causally related to the procedure, and not related to the stimulation or device.

Event Description

It was reported that the patient had a wound healing issue at the implantable pulse generator site area which was severe.The patient was hospitalized and administered medication.The event was assessed to be causally related to the device and procedure, and not device related.The device remains implanted and the event has resolved.Additional information was received that the event was causally related to the procedure, and not related to the stimulation or device.Additional information was received that during the patients hospitalization, the patient underwent a local wound revision with application of an antibacterial sleeve.

Event Description

It was reported that the patient had a wound healing issue at the implantable pulse generator site area which was severe.The patient was hospitalized and administered medication.The event was assessed to be causally related to the device and procedure, and not device related.The device remains implanted and the event has resolved.Additional information was received that the event was causally related to the procedure, and not related to the stimulation or device.Additional information was received that during the patients hospitalization, the patient underwent a local wound revision with the application of an antibacterial sleeve.Additional information was received that the event was assessed as an infection of the implantable pulse generator site.The event was probably related to the procedure, not related to the stimulation, and causally related to the device.

Event Description

It was reported that the clinical study patient had a wound healing issue at the implantable pulse generator site area which was severe.The patient was hospitalized and administered medication.The event was assessed to be causally related to the device and procedure, and not device related.The device remains implanted and the event has resolved.Additional information was received that the event was causally related to the procedure, and not related to the stimulation or device.Additional information was received that during the patients hospitalization, the patient underwent a local wound revision with the application of an antibacterial sleeve.Additional information was received that the event was assessed as an infection of the implantable pulse generator site.The event was probably related to the procedure, not related to the stimulation, and causally related to the device.

Manufacturer Narrative

Update to supplemental mdr 2, box b3 bsc aware date: additional information was received that the correct aware date was 24feb2022 not 28jun2022.

Event Description

It was reported that the clinical study patient had a wound healing issue at the implantable pulse generator site area which was severe.The patient was hospitalized and administered medication.The event was assessed to be causally related to the device and procedure, and not device related.The device remains implanted and the event has resolved.Additional information was received that the event was causally related to the procedure, and not related to the stimulation or device.Additional information was received that during the patients hospitalization, the patient underwent a local wound revision with the application of an antibacterial sleeve.Additional information was received that the event was assessed as an infection of the implantable pulse generator site.The event was probably related to the procedure, not related to the stimulation, and causally related to the device.Additional information was received that the event was assessed as possibly related to the procedure.The relationship to the device stimulation was reported as not related, and causally related to the device.

• Brand Name: VERCISE GEVIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 13518999
• MDR Text Key: 285528608
• Report Number: 3006630150-2022-00470
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2020
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 736076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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): Hospitalization; Required Intervention
• Patient Sex: Male