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

Model Number DB-2201-45-DC

Device Problems Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problem Shaking/Tremors (2515)

Event Date 08/23/2022

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced inadequate stimulation and the physician assessed that the leads migrated.Reprogrammings were attempted but they did not resolve the event.Therefore, the patient underwent a lead revision wherein both leads were explanted and replaced.There were no patient complications postoperatively.The explanted leads will not be returned as they were disposed of by the medical facility.

Manufacturer Narrative

Date of event: exact date unknown, event occurred in (b)(6) 2022.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db220145dc0, model: db-2201-45-dc, serial: (b)(4), batch: 7070100.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16578030
• MDR Text Key: 311654800
• Report Number: 3006630150-2023-01402
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: 08714729836544
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/09/2021
• Device Model Number: DB-2201-45-DC
• Device Catalogue Number: DB-2201-45-DC
• Device Lot Number: 5166650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2019
• 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 Sex: Male