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

Model Number DB-1416

Device Problems Premature Discharge of Battery (1057); Unexpected Therapeutic Results (1631); Battery Problem (2885)

Patient Problems Movement Disorder (4412); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced early depletion of the implantable pulse generator (ipg).The patient underwent a revision procedure where the ipg was replaced.The patient was doing well post-operatively.

Manufacturer Narrative

Engineers inspected and analyzed the returned device.The ipg was confirmed to have reached end of service eos state.The device was in service for a total of 4 months and 12 days with an average energy use index eui of 93.7 which confirmed high energy consumption use.The device longevity was within the expected range based on the eui measurement.Premature battery depletion was not confirmed.The device exhibited normal characteristics.A product labeling review identified that the device was used per the instructions for use ifu product label.Additionally, it states, when the stimulator battery is fully depleted, the end of service eos indicator will be displayed on the remote control and clinician programmer.Stimulation will not be available.Surgery is required to replace the implanted non rechargeable stimulator to continue providing stimulation.The longevity of the non rechargeable stimulator battery depends on the following factors, programmed parameters, system impedance, hours per day of stimulation, changes to stimulation made by the patient.Dystonia may be triggered by the loss of dbs therapy as well as by other factors and may lead to respiratory distress or failure, rhabdomyolysis, multiorgan failure, and death.Ensure that patients and caregivers understand the importance of maintaining dbs therapy and that its loss for any reason, accidental turnoff, battery depletion, and system failure could cause symptom return and are a known risks with the use of deep brain stimulation.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced early depletion of the implantable pulse generator (ipg).The patient underwent a revision procedure where the ipg was replaced.The patient was doing well post-operatively.Additional information was received indicating the patients dystonia symptoms returned due to the depletion of the ipg causing a loss of stimulation.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced early depletion of the implantable pulse generator (ipg).The patient underwent a revision procedure where the ipg was replaced.The patient was doing well post-operatively.Additional information was received indicating the symptoms the patient experienced due to the depletion of the ipg was dystonia.

• 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: 17782259
• MDR Text Key: 323851034
• Report Number: 3006630150-2023-05709
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/05/2023

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-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 214960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/08/2023; 11/06/2023
• Supplement Dates FDA Received: 11/01/2023; 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2022
• 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