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

Model Number DB-1140-S

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

Patient Problem Erosion (1750)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-ipg-pc, upn: m365db1140s0, model: db-1140-s, serial: (b)(6), batch: 631363; product family: dbs-extension, upn: unknown, model: unknown, serial: unknown, batch: unknown.

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent an implantable pulse generator (ipg) explant due to erosion at the ipg site.

• Brand Name: VERCISE PC
• 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: 18852738
• MDR Text Key: 337070239
• Report Number: 3006630150-2024-01251
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984467
• UDI-Public: 08714729984467
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2021
• Device Model Number: DB-1140-S
• Device Catalogue Number: DB-1140-S
• Device Lot Number: 630431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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 Age: 25 YR
• Patient Sex: Male