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 Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 03/01/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure due to an infection at the retromastoid area.The patients infection had puss seeping out and it was noted that the infection was caused by the cpap (continuous positive airway pressure) machine rubbing against the lead/extension connector.Nothing occurred in the patients recent procedure that may have caused the infection.The patient was treated with antibiotics for four months.A culture was performed, but results could not be obtained despite good faith efforts.The medical facility retained all explanted products and they will not be returned for analysis.

Manufacturer Narrative

Block b3: exact date unknown, event occurred in (b)(6) 2023.Additional suspect medical device component involved in the event: product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(6); batch: 7109188.Product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(6); batch: 7090199.Product family: dbs-lead fixation; upn: m365db4600c0; model: db-4600c; serial: n/a; batch: 28996647.

Manufacturer Narrative

Correction to block h6: impact codes.Block b3: exact date unknown, event occurred in (b)(6) 2023.Additional suspect medical device component involved in the event: 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-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 28996647.

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure due to an infection at the retromastoid area.The patients infection had puss seeping out and it was noted that the infection was caused by the cpap (continuous positive airway pressure) machine rubbing against the lead/extension connector.Nothing occurred in the patients recent procedure that may have caused the infection.The patient was treated with antibiotics for four months.A culture was performed, but results could not be obtained despite good faith efforts.The medical facility retained all explanted products and they will not be returned for analysis.

• 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: 17652300
• MDR Text Key: 322308029
• Report Number: 3006630150-2023-05186
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 09/22/2023

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 Expiration Date: 02/02/2024
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 533268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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: 67 YR
• Patient Sex: Male