MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

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.

• 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 Key: 17111092
• MDR Text Key: 317030703
• Report Number: 3006630150-2023-03326
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Date: 01/16/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 737079
• 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 Received: 06/12/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White