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

Model Number NM-3138-55

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

Patient Problems Bacterial Infection (1735); Erosion (1750); Discomfort (2330); Impaired Healing (2378)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Event date: exact date unknown, event occurred in (b)(6) 2022.Additional suspect medical device components involved in the event: product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7097627.Product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(4); batch: 7087376.Product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(4); batch: 7090119.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced impaired healing, erosion and irritation behind their right ear at the incision site where the lead and lead extension connect.The physician assessed that the device or procedure contributed to these patient complications.The patient was given antibiotics as a precaution.A culture was taken which confirmed the presence of pseudomonas aeruginosa infection.Therefore, the patient underwent a revision procedure wherein the lead and lead extension connections were repositioned and the incision area was cleaned.No devices were implanted or explanted during the procedure and the patient was doing well postoperatively.

• Brand Name: VERCISE
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15530093
• MDR Text Key: 301044441
• Report Number: 3006630150-2022-05218
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2024
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7096148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Race: White