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

Model Number DB-1216

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Impaired Healing (2378)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: n/i, model: n/i, serial: n/i, batch: n/i; product family: dbs-linear leads, upn: n/i, model: n/i, serial: n/i, batch: n/i.

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent a dbs system explant procedure due to an infection on the patients head and an ongoing issue with the patients skin not healing since the original implant surgery last year.There were no reported device issues and the physician assessed the infection as not device or procedure-related.The explanted devices were retained by the medical facility.In addition, the patient later developed a brain abscess after the revision procedure.The cause of the brain abscess is currently unknown.

Manufacturer Narrative

Additional suspect medical device components involved in the event: 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-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: (b)(6).Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: (b)(6).Product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600c.Serial: (b)(6).Batch: 29705193.Product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600c.Serial: (b)(6).Batch: 29998474.

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent a dbs system explant procedure due to an infection on the patients head and an ongoing issue with the patients skin not healing since the original implant surgery last year.There were no reported device issues and the physician assessed the infection as not device or procedure-related.The explanted devices were retained by the medical facility.In addition, the patient later developed a brain abscess after the revision procedure.The cause of the brain abscess is currently unknown.Additional information was received that the patient is at a rehabilitation facility to aid in their surgery recovery.

• Brand Name: VERCISE GENUS
• 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: 18263918
• MDR Text Key: 329667754
• Report Number: 3006630150-2023-07596
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 561539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Race: White