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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); Power Problem (3010); Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2023
Event Type  Injury  
Event Description
It was reported that following a non-device related procedure, the patient experienced a loss of stimulation, and the patients deep brain stimulation (dbs) implantable pulse generator (ipg) would not turn on.In addition, the ipg would no longer connect with the clinician programmer.The patient underwent a revision procedure in which the ipg was replaced.The procedure was completed successfully and there were no patient complications.
 
Event Description
It was reported that following a non-device related procedure, the patient experienced a loss of stimulation, and the patients deep brain stimulation (dbs) implantable pulse generator (ipg) would not turn on.In addition, the ipg would no longer connect with the clinician programmer.The patient underwent a revision procedure in which the ipg was replaced.The procedure was completed successfully and there were no patient complications.
 
Manufacturer Narrative
Db-1216, serial (b)(6): the returned ipg passed visual inspection.However, it was unable to be recharged after three four-hour charge cycles.It was cut open and the device exhibited high sleep current.Electrical testing revealed a low vh resistance measurement, which indicates an electrical short within the application-specific integrated circuit (asic).The damaged asic resulted in the premature battery depletion post non-device related procedure.This type of damage is typically caused when the ipg is exposed to high voltage transients, high current sources, and high radio frequency (rf) energy.Therefore, the ipg was likely damaged during the non-device related procedure.Additionally, a review of the instructions for use (ifu) revealed that medical therapies or procedures such as electrocautery may turn stimulation off or may cause permanent damage to the stimulator, particularly if used in close proximity to the device.The ifu further states that electrocautery can transfer destructive current into the dbs leads and-or stimulator.Electrocautery probes must be kept a minimum of 1 inch away from the implanted 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 Key17689000
MDR Text Key322697415
Report Number3006630150-2023-05333
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729985044
UDI-Public08714729985044
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 11/27/2023
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 Expiration Date05/05/2023
Device Model NumberDB-1216
Device Catalogue NumberDB-1216
Device Lot Number510871
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/06/2023
Supplement Dates Manufacturer Received11/03/2023
Supplement Dates FDA Received11/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2021
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;
Patient Age86 YR
Patient SexFemale
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