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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 Premature Discharge of Battery (1057)
Patient Problem Cramp(s) /Muscle Spasm(s) (4521)
Event Date 10/10/2022
Event Type  Injury  
Event Description
It was reported the patient experienced cramps that emitted a shock-like sensation as the implantable pulse generator (ipg) neared the end of life.Additionally, the physician assessed the ipg had depleted early, as the device was estimated to have a lifespan of five years based on the energy usage index (eui); however, the ipg reached the end of life (eol) after four years.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.
 
Manufacturer Narrative
The returned ipg passed the functional test, and the electrical test revealed normal device characteristics.Stimulation was monitored on an oscilloscope and the output was consistent and correct on all electrodes.Current leakage tests and residual gas analysis verified no loss of electric current from the ipg case.Impedance measurements with known good leads were within the expected range.Additionally, the ipg battery voltage was above the elective removal indicator (eri) threshold.Based on the patient stimulation settings, the energy use index (eui) indicates a projected battery lifespan of approximately 4.5 years.The ipg was in service for 3 years, 9 months, and 4 weeks when it was explanted; and engineers did not observe the end of life message during analysis of the device.Therefore, although it was reported that the ipg had reached eol and was removed after less than 4 years of service, engineers found no evidence of early battery depletion as all tests were passed, battery voltage was above eri threshold, and the eol message was not observed.Additionally, the patient experiencing cramping is a known risk of use with the dbs system as stated in the instructions for use.
 
Event Description
It was reported the patient experienced cramps that emitted a shock-like sensation as the implantable pulse generator (ipg) neared the end of life.Additionally, the physician assessed the ipg had depleted early, as the device was estimated to have a lifespan of five years based on the energy usage index (eui); however, the ipg reached the end of life (eol) after four years.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.
 
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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
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key15736846
MDR Text Key303096890
Report Number3006630150-2022-06000
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeFI
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 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/12/2020
Device Model NumberDB-1140
Device Catalogue NumberDB-1140
Device Lot Number631020
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2018
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;
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