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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 SYMPTOMS

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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-1200-S
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2023
Event Type  Injury  
Event Description
It was reported that the implantable pulse generator (ipg) could not communicate with the clinician programmer (cp).Engineers investigated and concluded that the ipg is most likely in a state that prohibits communication with all cps.Without the communication link to the cp, therapy settings could not be modified.Therefore, would be limiting any future therapy optimization for this patient.The patient underwent a revision procedure where the ipg was replaced.Post operatively, the patient was doing well.
 
Event Description
It was reported that the implantable pulse generator (ipg) could not communicate with the clinician programmer (cp).Engineers investigated and concluded that the ipg is most likely in a state that prohibits communication with all cps.Without the communication link to the cp, therapy settings could not be modified.Therefore, would be limiting any future therapy optimization for this patient.The patient underwent a revision procedure where the ipg was replaced.Post operatively, the patient was doing well.
 
Manufacturer Narrative
The ipg passed visual inspection and was able to be linked to a known good remote control and passed the functional test.However, the ipg was unable to link to a known good clinician programmer cp when using the vercise neural navigator 4 (vnn4) and an error code was displayed.After vnn4 was uninstalled and the vercise neural navigator 5 was installed, the ipg was able to connect and have the settings modified without any anomalies.The remote control was linked once again, and the amplitude changes made in the cp were reflected on the rc screen.The cause has been attributed to a rare communication error in an uncommon use of unlinking and relinking brainlab elements from cp the cp which is likely to occur when a wrong patient is chosen.
 
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Brand Name
VERCISE GEVIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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 Key17111092
MDR Text Key317030703
Report Number3006630150-2023-03326
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729984443
UDI-Public08714729984443
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/16/2021
Device Model NumberDB-1200-S
Device Catalogue NumberDB-1200-S
Device Lot Number737079
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/11/2023
Initial Date FDA Received06/12/2023
Supplement Dates Manufacturer Received07/20/2023
Supplement Dates FDA Received08/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2019
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 Age15 YR
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceWhite
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