• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-1200
Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892)
Patient Problem Movement Disorder (4412)
Event Date 10/05/2023
Event Type  Injury  
Event Description
It was reported that the patient experienced difficulty charging their implantable pulse generator (ipg).The patient was admitted to the hospital and it was discovered that the ipg was depleted which caused the ipg to switch off and therefore the patient experienced a loss of stimulation which resulted in a return in their parkinsons disease symptoms.The patient was re-educated on how to properly charge their ipg.The patient was then able to successfully charge their ipg and was discharged from the hospital.
 
Manufacturer Narrative
A database analysis was performed and there were no anomalies found in the battery discharge logs therefore the root cause of the charging issue could not be determined.
 
Event Description
It was reported that the patient experienced difficulty charging their implantable pulse generator (ipg).The patient was admitted to the hospital and it was discovered that the ipg was depleted which caused the ipg to switch off and therefore the patient experienced a loss of stimulation which resulted in a return in their parkinsons disease symptoms.The patient was re-educated on how to properly charge their ipg.The patient was then able to successfully charge their ipg and was discharged from the hospital.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERCISE GEVIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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 Key18178817
MDR Text Key328611857
Report Number3006630150-2023-07212
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P150031
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 01/08/2024
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? No
Device Operator Lay User/Patient
Device Expiration Date09/15/2022
Device Model NumberDB-1200
Device Catalogue NumberDB-1200
Device Lot Number744193
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2023
Initial Date FDA Received11/20/2023
Supplement Dates Manufacturer Received12/11/2023
Supplement Dates FDA Received01/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2020
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) Hospitalization;
-
-