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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-1200
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem No Code Available (3191)
Event Date 10/14/2019
Event Type  Injury  
Event Description
A report was received that the patient was no longer experiencing symptom relief.X-rays showed no migration of the leads and a database analysis revealed no anomalies with the ipg.The patient underwent an ipg explant.
 
Event Description
A report was received that the patient was no longer experiencing symptom relief.X-rays showed no migration of the leads and a database analysis revealed no anomalies with the ipg.The patient underwent an ipg explant.
 
Manufacturer Narrative
The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.The probable cause cannot be determined as no problem has been detected.
 
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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
MDR Report Key9941347
MDR Text Key187022025
Report Number3006630150-2020-01706
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/12/2021
Device Model NumberDB-1200
Device Catalogue NumberDB-1200
Device Lot Number737779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2020
Date Manufacturer Received06/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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