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 Implant Pain (4561)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7074594.Product family: upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7074737.

Event Description

It was reported that the deep brain stimulation (dbs) patient was experiencing pain at the site of the implantable pulse generator (ipg).X-ray imaging was performed to ensure the ipg had not migrated or flipped inside of the pocket.X-ray imaging did not reveal any anomalies.The physician decided to perform exploratory surgery to determine the cause of the pain and found nothing remarkable, however he decided to replace the ipg and lead extensions.The patient was doing well post-operatively.

Manufacturer Narrative

The returned ipg was analyzed and, passed all tests performed, and exhibited normal device characteristics.The dbs lead extensions nm-3138-55 serial numbers (b)(6) were not returned for analysis as they were retained by the hospital.Despite good faith efforts to obtain product return.A product labeling review identified that the ipg was used per ifu product label.Additionally, the ifu states that pain at the surgical site is a known risk with the use of deep brain stimulation.

Event Description

It was reported that the deep brain stimulation (dbs) patient was experiencing pain at the site of the implantable pulse generator (ipg).X-ray imaging was performed to ensure the ipg had not migrated or flipped inside of the pocket.X-ray imaging did not reveal any anomalies.The physician decided to perform exploratory surgery to determine the cause of the pain and found nothing remarkable, however he decided to replace the ipg and lead extensions.The patient was doing 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: 15353222
• MDR Text Key: 299270292
• Report Number: 3006630150-2022-04501
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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 Expiration Date: 01/09/2024
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 527929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2022
• 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 Sex: Female