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

Model Number DB-1200

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Shaking/Tremors (2515); Speech Disorder (4415); Unspecified Musculoskeletal problem (4535)

Event Date 02/16/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced loss of stimulation and an increase of rigidity, dysarthria, and tremors.Reprogramming was performed, but the patient did not have the same coverage.The patients device settings were reviewed and when the system was turned off, the increased symptoms disappeared.The patients impedances are within normal range, but the patient increases their medication to compensate for the stimulation issues.Database analysis was performed and no device anomalies were found.An x-ray was also taken and the physician found no issues.The patient then underwent a revision procedure to explant and replace the implantable pulse generator (ipg).The patient is stable and doing well postoperatively.

Manufacturer Narrative

With all available information, boston scientific concludes through laboratory analysis that the event loss of stimulation and the increase of rigidity, dysarthria, and tremors were not able to be confirmed as the ipg passed all tests performed.Additionally, the event of the increase of rigidity, dysarthria, and tremors are known inherent risks with the use of deep brain stimulation as documented in the instructions for use (ifu).The returned db-1200 ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.The ifu states that the following is a list of known risks with the use of deep brain stimulation: embolism, including air embolism and pulmonary embolism, hemorrhagic or ischemic stroke, immediate or delayed, which could result in temporary or permanent neurologic deficits such as muscle weakness, paralysis or aphasia peripheral nerves, brain (including pneumocephalus), or pleura (including pneumothorax), loss of adequate stimulation, mentation impairment such as attention or cognitive deficits, memory disturbances, or confusion, motor problems such as paresis, weakness, incoordination, restlessness, muscle spasms, postural and gait disorders, tremor, dystonia, or dyskinesias, and falls or injuries resulting from these problem, musculoskeletal stiffness, neuroleptic malignant syndrome or acute akinesia can occur very rarely, overstimulation or undesirable sensations, such as paresthesia, transient or persistent, pain, headache or discomfort, transient or persistent, including symptoms due to neurostimulation.

Event Description

It was reported that the patient experienced an increase of rigidity, dysarthria, and loss of stimulation.Reprogramming was performed, but the patient did not have the same coverage.The patient's device settings were reviewed and when the system was turned off, the increased symptoms disappeared.The patient's device exhibits good impedances, but the patient increases their medication to compensate for the inadequate stimulation.An x-ray was taken and the physician found no issues.The patient then underwent a revision procedure to explant and replace the implantable pulse generator (ipg).The patient is stable and doing well postoperatively.

• Brand Name: VERCISE GEVIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13582803
• MDR Text Key: 285982943
• Report Number: 3006630150-2022-00643
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 21449255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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