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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 Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Inappropriate or Unexpected Reset (2959); Intermittent Energy Output (4025)
Patient Problems Anxiety (2328); Discomfort (2330)
Event Date 07/13/2023
Event Type  malfunction  
Event Description
It was reported that the patient felt the deep brain stimulation (dbs) system turn off while charging the system on multiple occasions.The patient was distressed when they then experienced temporary uncomfortable shocking sensations.The patient was advised to return to the place in their home where they typically charge the device to reduce interference.The database analysis performed identified a bluetooth fault code when charging the implantable pulse generator (ipg).Noise from the charging field of the charger interferes with the bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.No other anomalies were found with the analysis as the device displayed a normal charge log.The ipg remains implanted in the patient and delivering therapy.
 
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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 Key18213669
MDR Text Key329686012
Report Number3006630150-2023-07387
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729985044
UDI-Public08714729985044
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 11/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDB-1216
Device Catalogue NumberDB-1216
Device Lot Number563545
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/20/2023
Initial Date FDA Received11/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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