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

Model Number DB-2201-30-DC

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

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 11/20/2021

Event Type  Injury  

Event Description

It was reported that the patient's deep brain stimulation (dbs) lead was exposed from the patient's scalp.The device remains implanted but is no longer being used by the patient until a resolution can be determined by the physician.

Event Description

It was reported that the patient's deep brain stimulation (dbs) lead was exposed from the patient's scalp.The device remains implanted but is no longer being used by the patient until a resolution can be determined by the physician.Additional information was received that the patient underwent a system explant procedure where all the implanted devices were removed.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads; upn: ni; model: ni; serial: (b)(6); batch: ni.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-ipg-r-mri, upn: m365db12000, model: db-1200, serial: (b)(6) batch: (b)(6).Product family: dbs-linear leads, upn: m365db220130dc0, model: db-2201-30dc, serial: (b)(6), batch: 19125943.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: (b)(6).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: (b)(6).Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 19312126.

Event Description

It was reported that the patient's deep brain stimulation (dbs) lead was exposed from the patient's scalp.The device remains implanted but is no longer being used by the patient until a resolution can be determined by the physician.Additional information was received that the patient underwent a system explant procedure where all the implanted devices were removed.Additional information was received that the physician suspected that the patient had an infection due to the erosion issue.Therefore, the patient underwent a system explant, however it was later confirmed that the patient did not exhibit noticeable signs of infection.The patient was doing fine post-operatively and the explanted devices will not be returned as they were discarded by the facility.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13054081
• MDR Text Key: 282575586
• Report Number: 3006630150-2021-07151
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/07/2018
• Device Model Number: DB-2201-30-DC
• Device Catalogue Number: DB-2201-30-DC
• Device Lot Number: 19000987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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