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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 Use of Device Problem (1670); Charging Problem (2892)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2023
Event Type  Injury  
Event Description
It was reported that the patient experienced difficulty charging their deep brain stimulation (dbs) implantable pulse generator (ipg).The physician believes that the ipg may have malfunctioned when the patient had a different surgery last month and the ipg was put into mri mode.It was unknown if electrocautery was used during the previous procedure.After trying a new remote control and charger, the ipg still did not charge.The patient underwent a revision procedure and the ipg was explanted and replaced.The patient was doing well postoperatively.
 
Manufacturer Narrative
The reported event of the patient experiencing difficulty charging their dbs ipg was confirmed through technical analysis of the returned device.The ipg passed visual inspection and was unable to recharged.It was cut open and it was revealed that the battery exhibited a high sleep current.Electrical testing revealed a low resistance measurement, which indicates an electrical short within the application-specific integrated circuit (asic).The damaged asic resulted in the premature battery depletion post implant.This type of damage is typically caused when the ipg is exposed to high voltage/current transients or high radiofrequency (rf) energy.Exposure to electrocautery can cause this type of damage.It is unknown if electrocautery was used during the surgery.A labeling review was performed and did not reveal any anomalies as the instructions for use (ifu) states that patients implanted with the full vercise pc dbs system (dbs leads, lead extensions, and stimulator) should not be subjected to magnetic resonance imaging (mri).Mri exposure may result in the following: dislodgement of implanted components and/or damage to the stimulators electronics.
 
Event Description
It was reported that the patient experienced difficulty charging their deep brain stimulation (dbs) implantable pulse generator (ipg).The physician believes that the ipg may have malfunctioned when the patient had a different surgery last month and the ipg was put into mri mode.It was unknown if electrocautery was used during the previous procedure.After trying a new remote control and charger, the ipg still did not charge.The patient underwent a revision procedure and the ipg was explanted and replaced.The patient was doing well postoperatively.
 
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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 Key17053704
MDR Text Key316443199
Report Number3006630150-2023-03143
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/05/2023
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 NumberDB-1216
Device Catalogue NumberDB-1216
Device Lot Number555957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2023
Initial Date FDA Received06/02/2023
Supplement Dates Manufacturer Received06/07/2023
Supplement Dates FDA Received07/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2022
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 Age76 YR
Patient SexMale
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