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 Problem Unspecified Infection (1930)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: m365db2202450.Model: db-2202-45.Serial: (b)(6) batch: 7099597.Product family: dbs-linear leads upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7098124.Product family: dbs-extension upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7114861.

Event Description

It was reported that there was a suspected infection at the patients deep brain stimulation (dbs) implant site during a follow up visit.The physicians assessment confirmed that no infection was present during examination however the patient underwent a procedure where the dbs lead extension incision was reopened and cleaned out before re-suturing incision per the physicians preference.It is unknown which lead extension site was addressed.The patient did well post-operatively.

Manufacturer Narrative

Additional information to the initial mdr in blocks a1, a2, a3.A4, a5 and a6.

Event Description

It was reported that there was a suspected infection at the patients deep brain stimulation (dbs) implant site during a follow up visit.The physicians assessment confirmed that no infection was present during examination however the patient underwent a procedure where the dbs lead extension incision was reopened and cleaned out before re-suturing incision per the physicians preference.It is unknown which lead extension site was addressed.The patient did well post-operatively.

• 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: 18704381
• MDR Text Key: 335369183
• Report Number: 3006630150-2024-00676
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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
• Report Date: 03/14/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 558615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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: Female