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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 Problem Intermittent Energy Output (4025)
Patient Problems Numbness (2415); Shaking/Tremors (2515); Paresthesia (4421)
Event Date 12/30/2023
Event Type  malfunction  
Event Description
It was reported that the patient experienced numbness and tingling while charging the deep brain stimulation (dbs) implantable pulse generator (ipg) on several occasions.The database analysis performed identified a bluetooth fault code when charging the ipg.Noise from the charging field for 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 and all impedances were within expected range.The ipg had a firmware update, and the issue has since resolved 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 Key18681978
MDR Text Key336309161
Report Number3006630150-2024-00610
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/09/2024
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 Model NumberDB-1216
Device Catalogue NumberDB-1216
Device Lot Number551461
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/16/2024
Initial Date FDA Received02/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2022
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;
Patient Age78 YR
Patient SexMale
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