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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-1216
Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892)
Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Ventricular Fibrillation (2130)
Event Date 08/29/2023
Event Type  Injury  
Event Description
It was reported that the deep brain stimulation (dbs) patient was swimming in the sea and a few minutes later, had to undergo resuscitation and defibrillation for more than thirty minutes after experiencing a sudden cardiac death.The patient also experienced a phase of hypoxia and ventricular fibrillation and was later hospitalized.While at the hospital, the patient experienced charging difficulties with the battery depleting faster than expected.Since the patient was intubated, it was unclear if the stimulation was on.The physician assessed that it was unclear if the stimulation issue was caused by the defibrillation.The patient was discharged from the hospital.However, a few weeks later, the patient underwent a revision procedure to explant and replace the implantable pulse generator (ipg) due to inadequate stimulation and charging difficulties.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient was swimming in the sea and a few minutes later, had to undergo resuscitation and defibrillation for more than thirty minutes after experiencing a sudden cardiac death.The patient also experienced a phase of hypoxia and ventricular fibrillation and was later hospitalized.While at the hospital, the patient experienced charging difficulties with the battery depleting faster than expected.Since the patient was intubated, it was unclear if the stimulation was on.The physician assessed that it was unclear if the stimulation issue was caused by the defibrillation.The patient was discharged from the hospital.However, a few weeks later, the patient underwent a revision procedure to explant and replace the implantable pulse generator (ipg) due to inadequate stimulation and charging difficulties.
 
Manufacturer Narrative
With the available information, boston scientific concludes that the reported event of the patient experiencing charging difficulties and inadequate stimulation was confirmed through device analysis.The returned ipg had an excessive sleep current and damaged application specific integrated circuit (asic) chip, which was likely a result of the defibrillation to which the patient was exposed.Therefore, the excessive current draw from the damaged asic likely resulted in the reported event of the ipg charging difficulties and inadequate stimulation.The returned ipg revealed normal characteristics during the visual examination.However, the system log revealed a fast depletion rate with the stimulation off, which is above the expected range.This behavior was observed after timestamp (b)(6) and the functional test revealed that the quiescent current test and the mri capacitor test were out of the expected range.The internal electrical measurements confirmed an excessive sleep current and that the asic chip was damaged.
 
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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 Key18271698
MDR Text Key329774363
Report Number3006630150-2023-07632
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeGM
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 02/23/2024
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 Date06/30/2023
Device Model NumberDB-1216
Device Catalogue NumberDB-1216
Device Lot Number515939
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/08/2023
Initial Date FDA Received12/05/2023
Supplement Dates Manufacturer Received01/29/2024
Supplement Dates FDA Received02/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2021
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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