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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-1110-C
Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993); Wireless Communication Problem (3283)
Patient Problem Shaking/Tremors (2515)
Event Date 11/06/2023
Event Type  Injury  
Event Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate therapy of his tremor symptoms, as his dbs device was unable to be charged and the remote control was unable to communicate with the implantable pulse generator (ipg).Troubleshooting of the remote control and charger did not resolve the issue.Therefore, the patient was hospitalized and medication was adjusted.Additionally, the patient underwent an ipg revision procedure during which the ipg was explanted and replaced.The patient was doing well postoperatively and his tremor symptoms have resolved.
 
Manufacturer Narrative
Device analysis performed on the returned ipg revealed normal device characteristics during visual and functional examination.Additionally, the ipg was able to be charged in one four-hour cycle with no anomalies.However, the data log revealed the thermistor had been triggered multiple times.An x-ray inspection also revealed a damaged spring contact that was likely damaged during the explant procedure.A product labeling review that was conducted determined that lead breakage, loose connections or electrical issues can result in inadequate stimulation and the ipg should not be charged if the ambient temperature is above 35 degrees celcius.Therefore, these are known inherent risks with use of the dbs device, as documented in the ifu.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient experienced inadequate therapy of his tremor symptoms, as his dbs device was unable to be charged and the remote control was unable to communicate with the implantable pulse generator (ipg).Troubleshooting of the remote control and charger did not resolve the issue.Therefore, the patient was hospitalized and medication was adjusted.Additionally, the patient underwent an ipg revision procedure during which the ipg was explanted and replaced.The patient was doing well postoperatively and his tremor symptoms have resolved.
 
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Brand Name
VERCISE
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 Key18307562
MDR Text Key330222772
Report Number3006630150-2023-07784
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeUK
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 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/07/2017
Device Model NumberDB-1110-C
Device Catalogue NumberDB-1110-C
Device Lot Number17553434
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2015
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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