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

Model Number	DB-9218-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-adapters, upn: m365db9218150, model: db-9218-15 , serial: (b)(4), lot: (b)(4).
Event or Problem Description
It was reported that the patient experienced an infection with puss and redness near the deep brain stimulation lead adapter site.The patient underwent a surgical procedure where the infected site was irrigated and cleaned.The patient was administered oral antibiotics and was doing well post operatively.The device remains implanted.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-adapters, upn: m365db9218150, model: db-9218-15, serial: (b)(6), lot: 7073938; product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: (b)(6), lot: 542581.
Event or Problem Description
It was reported that the patient experienced an infection with puss and redness near the deep brain stimulation lead adapter site.The patient underwent a surgical procedure where the infected site was irrigated and cleaned.The patient was administered oral antibiotics and was doing well post operatively.The device remains implanted.Additional information was received that the patient experienced an infection and erosion behind the ear at the non-boston scientific lead extension site.The patient then underwent a system explant procedure and was recovering postoperatively.The devices will not be returned as they were disposed of by the medical facility.

• Brand Name: VERCISE
• Common Device Name: 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16218843
• Report Number: 3006630150-2023-00170
• Device Sequence Number: 7492574
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2022
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7071635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male