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

Model Number DB-1216

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

It was reported that the deep brain stimulation (dbs) patients implantable pulse generator (ipg) was depleting quickly post-implant surgery and the remote control (rc) displayed an error message that the battery was low.It was confirmed that monopolar cautery was not used during the implant procedure.Therefore, a database analysis was performed which confirmed the reported event of battery depletion prior to initial programming.The battery depleted from 4.0 volts to 3.4 volts during a two week period however, the root cause of this depletion was unable to be established without a return analysis as the ipg remains implanted.

Event Description

It was reported that the deep brain stimulation (dbs) patients implantable pulse generator (ipg) was depleting quickly post-implant surgery and the remote control (rc) displayed an error message that the battery was low.It was confirmed that monopolar cautery was not used during the implant procedure.Therefore, a database analysis was performed which confirmed the reported event of battery depletion prior to initial programming.The battery depleted from 4.0 volts to 3.4 volts during a two week period however, the root cause of this depletion was unable to be established without a return analysis as the ipg remains implanted.Additional information was received that the patient was doing well and was no longer having any charging issues.

Event Description

It was reported that the deep brain stimulation (dbs) patients implantable pulse generator (ipg) was depleting quickly post-implant surgery and the remote control (rc) displayed an error message that the battery was low.It was confirmed that monopolar cautery was not used during the implant procedure.Therefore, a database analysis was performed which confirmed the reported event of battery depletion prior to initial programming.The battery depleted from 4.0 volts to 3.4 volts during a two week period however, the root cause of this depletion was unable to be established without a return analysis as the ipg remains implanted.Additional information was received that the patient was doing well and was no longer having any charging issues.

Manufacturer Narrative

A second database analysis was performed which did not reveal any further deviations in normal ipg behavior since the unexpected depletion that was noted in the first database analysis.Therefore, the root cause of this depletion remains unable to be established without the return of the ipg.

• 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: 17513380
• MDR Text Key: 320929967
• Report Number: 3006630150-2023-04718
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2023

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: 569047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 08/15/2023; 09/19/2023
• Supplement Dates FDA Received: 09/12/2023; 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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