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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-1140
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Skin Inflammation/ Irritation (4545)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative
It is indicated that the device will not be returned for evaluation as it remains implanted in the patient therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
A report was received that the patient developed scar irritation and pulling of scar tissue.The patient was admitted and underwent a revision procedure of the ipg, and nothing was implanted or explanted.The event resolved and the patient was discharged.The event was assessed as possibly device and procedure related and unlikely related to the stimulation.The patient was discharged and the event resolved.
 
Event Description
A report was received that the patient developed scar irritation and pulling of scar tissue.The patient was admitted and underwent a revision procedure of the ipg, and nothing was implanted or explanted.The event resolved and the patient was discharged.The event was assessed as possibly device and procedure related and unlikely related to the stimulation.The patient was discharged and the event resolved.
 
Manufacturer Narrative
Update to box d6a implant date.
 
Manufacturer Narrative
Update to box h6 conclusion code.
 
Event Description
A report was received that the patient developed scar irritation and pulling of scar tissue.The patient was admitted and underwent a revision procedure of the ipg, and nothing was implanted or explanted.The event resolved and the patient was discharged.The event was assessed as possibly device and procedure related and unlikely related to the stimulation.The patient was discharged and the event resolved.
 
Event Description
A report was received that the patient developed scar irritation and pulling of scar tissue.The patient was admitted and underwent a revision procedure of the ipg, and nothing was implanted or explanted.The event resolved and the patient was discharged.The event was assessed as possibly device and procedure related and unlikely related to the stimulation.The patient was discharged and the event resolved.
 
Manufacturer Narrative
Update to box d6a implant date.
 
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Brand Name
VERCISE PC
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
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key9447825
MDR Text Key170207240
Report Number3006630150-2019-07222
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 12/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/14/2019
Device Model NumberDB-1140
Device Catalogue NumberDB-1140
Device Lot Number20382934
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2017
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; Required Intervention;
Patient SexMale
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