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

Model Number DB-1216

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: exact date unknown, event occurred approximately a month before the aware date.

Event Description

It was reported that the patient experienced undesired sensations while charging the deep brain stimulation (dbs) implantable pulse generator (ipg).The database analysis performed identified a bluetooth fault code when charging the implantable pulse generator (ipg).Noise from the charging field of the charger interferes with the bluetooth communication chip set, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.No other anomalies were found with the analysis as the device displayed a normal charge log.The ipg remains implanted in the patient and delivering therapy.A firmware update was completed on the ipg.

Event Description

It was reported that the patient experienced undesired sensations while charging the deep brain stimulation (dbs) implantable pulse generator (ipg).The database analysis performed identified a bluetooth fault code when charging the implantable pulse generator (ipg).Noise from the charging field of the charger interferes with the bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation.No other anomalies were found with the analysis as the device displayed a normal charge log.The ipg remains implanted in the patient and delivering therapy.A firmware update was completed on the ipg.Additional information received that the firmware update was successful, and the reported patient charging issues were resolved.

• Brand Name: VERCISE GENUS
• 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: 18731610
• MDR Text Key: 336508226
• Report Number: 3006630150-2024-00800
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 545244
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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 Age: 70 YR
• Patient Sex: Male