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

Model Number DB-1232

Device Problems Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283); Intermittent Energy Output (4025)

Patient Problem Shaking/Tremors (2515)

Event Date 12/21/2022

Event Type  malfunction  

Event Description

It was reported the deep brain stimulation (dbs) patient experienced a temporary loss of stimulation while charging, resulting in a return of their tremors and momentary implantable pulse generator (ipg) to remote communication issues.Attempts to reprogram the device were not successful.However, a database analysis performed identified a bluetooth fault 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.

Event Description

It was reported the deep brain stimulation (dbs) patient experienced a temporary loss of stimulation while charging, resulting in a return of their tremors and momentary implantable pulse generator (ipg) to remote communication issues.Attempts to reprogram the device were not successful.However, a database analysis performed identified a bluetooth fault 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 was received that the patient underwent a procedure where the ipg was replaced with another of a different model.The patient did well post-operatively.

Manufacturer Narrative

The returned vercise genus implantable pulse generator (ipg) was analyzed and revealed normal characteristics and passed functional testing.However, a database analysis performed identified a bluetooth fault 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 for 10-15 seconds and returns to normal operation.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states failure or malfunction and worsening of disease symptoms caused by loss of stimulation are known risks with the use of dbs.With all the available information boston scientific concludes the temporary loss of stimulation during charging was due to a bluetooth fault and determined the probable cause was traced to device design.

Event Description

It was reported the deep brain stimulation (dbs) patient experienced a temporary loss of stimulation while charging, resulting in a return of their tremors and momentary implantable pulse generator (ipg) to remote communication issues.Attempts to reprogram the device were not successful.However, a database analysis performed identified a bluetooth fault 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 was received that the patient underwent a procedure where the ipg was replaced with another of a different model.The patient did well post-operatively.

• 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: 18243672
• MDR Text Key: 329452979
• Report Number: 3006630150-2023-07473
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985051
• UDI-Public: 08714729985051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,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-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 535538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 02/08/2024
• Supplement Dates FDA Received: 01/05/2024; 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2022
• 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: 75 YR
• Patient Sex: Male