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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-1416
Device Problems Unexpected Therapeutic Results (1631); Defective Device (2588)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2023
Event Type  Injury  
Event Description
It was reported that the deep brain stimulation (dbs) patient did not receive an elective replacement indication (eri) message prior to the end of life (eol) for the implantable pulse generator (ipg).The patient experienced a loss of stimulation therapy due to the eol and therefore, underwent an urgent revision procedure where the ipg was replaced.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient did not receive an elective replacement indication (eri) message prior to the end of life (eol) of the implantable pulse generator (ipg).The patient underwent a revision procedure to explant and replace the ipg since the patient was no longer receiving any stimulation.
 
Manufacturer Narrative
The returned ipg was received at the eos state.The data log analysis revealed that the ipg reached eri at timestamp 1694869337 (approx.(b)(6) 2023), and the eos happened at 2 years, 6 months, and 23.5 days after the initial active programming.The average energy use index (eui) was 14.The ipg exhibited normal characteristics during the visual and functional examination.A product labeling review identified that the device was used per the instructions for use (ifu) product label and it did not reveal any anomalies.The ifu states that when the implanted non-rechargeable stimulator is nearing the end of its battery life, the stimulator will enter the elective replacement mode.The elective replacement indicator (eri) will appear on the remote control and clinician programmer.Stimulation is still being provided during this eri period.Changes made to the stimulation will not be saved, and stimulation will not be available soon.Patients should be advised to contact their healthcare provider to report this message screen.The stimulator must be replaced to continue receiving stimulation.Batteries that have lasted 12 months or more without entering eri mode will have a minimum of 4 weeks between entering eri mode and reaching the end of battery life.Surgery is required to replace the implanted non rechargeable stimulator.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.Based on all available information, the reported event of the patient experiencing loss of stimulation and not receiving an elective replacement indicator (eri) message before the end of service (eos) of the implantable pulse generator (ipg) could not be confirmed through device analysis.The ipg did not reveal any signs of premature battery depletion.However, the labeling indicates that batteries that have lasted 12 months or more without entering eri mode will have a minimum of 4 weeks between entering eri mode and reaching the end of battery life.Stimulation is still being provided during this eri period.It is most likely that the user was not aware of the eri message when it was displayed on the remote control.It was also reported that the patient was no longer receiving stimulation.The labeling states that when the stimulator battery is fully depleted, the eos indicator will be displayed and stimulation will not be available at this time.Therefore, it was determined that no problem was detected with the device.
 
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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 Key18332751
MDR Text Key330545748
Report Number3006630150-2023-07856
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729985020
UDI-Public08714729985020
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
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 03/22/2024
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 Expiration Date07/28/2022
Device Model NumberDB-1416
Device Catalogue NumberDB-1416
Device Lot Number200934
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/20/2023
Initial Date FDA Received12/14/2023
Supplement Dates Manufacturer Received02/26/2024
Supplement Dates FDA Received03/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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