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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 Problems Premature Discharge of Battery (1057); Unexpected Therapeutic Results (1631); Power Problem (3010)
Patient Problems Pain (1994); Discomfort (2330); Depression (2361); Inadequate Pain Relief (2388); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 10/05/2021
Event Type  malfunction  
Event Description
It was reported that the spinal cord stimulator patient was unable to charge her ipg and experiencing inadequate stimulation.The physician assessed that the ipg had prematurely depleted and the patient underwent an ipg revision procedure.
 
Event Description
It was reported that the patient was unable to charge her implantable pulse generator (ipg) and experiencing inadequate stimulation.The physician assessed that the ipg had prematurely depleted and the patient underwent an ipg revision procedure.
 
Manufacturer Narrative
Correction to the initial mdr in block: b5.
 
Event Description
It was reported that the patient was unable to charge her implantable pulse generator (ipg) and experiencing inadequate stimulation.The physician assessed that the ipg had prematurely depleted and the patient underwent an ipg revision procedure.
 
Manufacturer Narrative
The returned ipg was analyzed and it confirmed premature battery depletion.Analysis of the patients database revealed the ipg was in service for approximately 6 months 18 days with an energy use index (eui) range of 20.5, and the expected range would be about 24 months per the direction for use.The patients data also shows a sudden battery drop at the time of the implant procedure, from 2.992 volts to 2.884 volts.The analysis did confirm that the incident shortened the devices longevity significantly.
 
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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
cashel road
clonmel
EI  
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12722301
MDR Text Key279262107
Report Number3006630150-2021-06080
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup
Report Date 06/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/02/2021
Device Model NumberDB-1140
Device Catalogue NumberDB-1140
Device Lot Number632613
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2019
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 SexFemale
Patient RaceWhite
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