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

Model Number DB-1216

Device Problems Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  Injury  

Event Description

It was reported that a deep brain stimulation (dbs) patient experienced cognitive issues and was admitted to the emergency room (er).The patient presented himself to the er with no remote control and dbs implantable pulse generator (ipg) was unreadable since the device was not charged per the physicians assessment.The patient underwent a procedure where the ipg was replaced with another of a different model four days later from being admitted.Physical analysis of the dbs ipg was not performed as it was retained by the facility.The patient did well post-operatively.

Event Description

It was reported that a deep brain stimulation (dbs) patient experienced cognitive issues and was admitted to the emergency room (er).The patient presented himself to the er with no remote control and dbs implantable pulse generator (ipg) was unreadable since the device was not charged per the physicians assessment.The patient underwent a procedure where the ipg was replaced with another of a different model four days later from being admitted.Physical analysis of the dbs ipg was not performed as it was retained by the facility.The patient did well post-operatively.Additional information received that the patient was non-compliant and didn't have the ability to recharge the device as a result the physician decided to replace the ipg with a non-rechargeable ipg.There were no malfunctions with the rechargeable ipg other than being depleted of charge per the physicians assessment.

• 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: 18481054
• MDR Text Key: 332489694
• Report Number: 3006630150-2023-08516
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: 07/07/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 516310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male