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

Model Number DB-1200-S

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

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Head Injury (1879); Inflammation (1932)

Event Date 08/23/2022

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-extension upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7101363, product family: dbs-extension.Upn: m365nm3138550, model: nm-3138-55, serial:(b)(4), batch: 7100199, product family: dbs-linear leads.Upn: m365db2202450, model: db-2202-45, serial:(b)(4), batch: 7090070, product family: dbs-linear leads.Upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: 7092796, product family: dbs-lead fixation.Upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 28996643.Product family: dbs-lead fixation.Upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 29077364.

Event Description

It was reported that the patient experienced a head injury and developed inflammation at their deep brain stimulation (dbs) implant site.The physician noted that the patients head injury exposed the dbs hardware and assessed a wound dehiscence caused the infection.Cultures were taken revealed staphylococcus aureus.The patient underwent an explant procedure where the entire dbs system was removed and were prescribed anti-biotics.The patient did well post-operatively, the devices were discarded by the facility and will not return for analysis.

• Brand Name: VERCISE GEVIA
• 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: 16685573
• MDR Text Key: 312732696
• Report Number: 3006630150-2023-01808
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• 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
• Report Date: 04/05/2023

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 Expiration Date: 07/02/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 743173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• 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
• Patient Age: 55 YR
• Patient Sex: Female