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

Model Number DB-1216

Device Problem Intermittent Energy Output (4025)

Patient Problem Paresthesia (4421)

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported that the patient experienced a pins and needles sensation while charging the deep brain stimulation (dbs) implantable pulse generator (ipg).The database analysis performed identified a bluetooth fault code when charging the 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.The ipg remains implanted in the patient and delivering therapy.

Event Description

It was reported that the patient experienced a pins and needles sensation while charging the deep brain stimulation (dbs) implantable pulse generator (ipg).The database analysis performed identified a bluetooth fault code when charging the 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.The ipg remains implanted in the patient and delivering therapy.Additional information received indicates that a boston scientific representative, in consultation with the treating clinician, performed an ipg firmware update that has resolved the bluetooth fault code error when charging the ipg.The applicable firmware is model 9028506-102-00.

Event Description

It was reported that the patient experienced a pins and needles sensation while charging the deep brain stimulation (dbs) implantable pulse generator (ipg).The database analysis performed identified a bluetooth fault code when charging the 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.The ipg remains implanted in the patient and delivering therapy.Additional information received indicates that a boston scientific representative, in consultation with the treating clinician, performed an ipg firmware update that has resolved the bluetooth fault code error when charging the ipg.The applicable firmware is model 9028506-102-00.

• 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: 18735727
• MDR Text Key: 336508150
• Report Number: 3006630150-2024-00798
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2024

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: 583362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 03/04/2024; 04/01/2024
• Supplement Dates FDA Received: 03/29/2024; 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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: 66 YR
• Patient Sex: Female