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 Bacterial Infection (1735)

Event Date 02/01/2024

Event Type  Injury  

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: 7106454; product family: dbs-extension upn: m365nm3138550; model: nm-3138-55; serial: (b)(6); batch: 7106591.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a staph infection at both the implantable pulse generator (ipg) site and the lead and lead extension sites wherein showing signs of redness.The patient was administered antibiotics.The patient underwent a revision procedure where the full dbs system was explanted.The patient was doing well post-operatively.The explanted devices were retained by the facility and were not returned to bsc.

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: 7112609.Product family: dbs-linear leads: upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7112679.Product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600c.Serial: n/a.Batch: 32803889.Product family: dbs-lead fixation: upn: m365db4600c0.Model: db-4600c.Serial: n/a.Batch: 32445505.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a staph infection at both the implantable pulse generator (ipg) site and the lead and lead extension sites wherein showing signs of redness.The patient was administered antibiotics.The patient underwent a revision procedure where the full dbs system was explanted.The patient was doing well post-operatively.The explanted devices were retained by the facility and were not returned to bsc.Additional information was received providing the model and serial number of the leads and burr hole covers that were also explanted during the explant procedure.

• 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: 18866421
• MDR Text Key: 337225825
• Report Number: 3006630150-2024-01337
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• 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: 03/19/2024

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 Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 588707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2023
• 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: 60 YR
• Patient Sex: Male