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

Model Number DB-1200-S

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

Patient Problems Depression (2361); Shaking/Tremors (2515)

Event Date 10/28/2020

Event Type  Injury  

Event Description

It was reported by the deep brain stimulation (dbs) patient that two days after the implant procedure the tremor returned and was worse.The patient explained that the when the stimulation was turned on the tremor was better than when the stimulation was turned off.The patient could no longer feed herself, go to the bathroom independently, she was living in an assisted living home and was depressed.The physician attempted reprogramming twice a week for a year but the issue remained.The physician did not believe the device or procedure contributed to the worsening of the tremor but rather it was a result of the progression of the patient's condition.The physician revised the patient even though there was a small chance of improvement.After the revision procedure, the left replacement lead was confirmed by computed tomography (ct) to be off target so the patient was brought back to the operating room (or), later that evening, and a new lead was placed in the target location.The patient was doing well post-operatively.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(4).Batch: 7076450.Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(4).Batch: 7076603.Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(4).Batch: 7093916.

Event Description

It was reported by the deep brain stimulation (dbs) patient that two days after the implant procedure the tremor returned and was worse.The patient explained that the when the stimulation was turned on the tremor was better than when the stimulation was turned off.The patient could no longer feed herself, go to the bathroom independently, she was living in an assisted living home and was depressed.The physician attempted reprogramming twice a week for a year but the issue remained.The physician did not believe the device or procedure contributed to the worsening of the tremor but rather it was a result of the progression of the patient's condition.The physician revised the patient even though there was a small chance of improvement.After the revision procedure, the left replacement lead was confirmed by computed tomography (ct) to be off target so the patient was brought back to the operating room (or), later that evening, and a new lead was placed in the target location.The patient was doing well post-operatively.The explanted leads were discarded by the facility.

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: 7076450.Product family: dbs-linear leads upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7076603.Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7093916.Correction to the initial mdr in field b5.The explanted leads were not returned as they were discarded by the facility.Analysis of the returned ipg indicated that the ipg passed all tests performed.However, the device exhibited an electrocautery burn mark on the front face of the case.The damage resulted from the explant procedure and is not considered a failure.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Additionally, the ifu states that worsening of disease symptoms, potentially caused by loss of stimulation, medication changes, surgery or illness are known risks with the use of dbs.

• Brand Name: VERCISE GEVIA
• 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: 15392221
• MDR Text Key: 299580687
• Report Number: 3006630150-2022-04649
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

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: 09/15/2022
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 744209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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: 81 YR
• Patient Sex: Female