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

Model Number DB-1416

Device Problem Battery Problem (2885)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

It was reported that the patient received the elective replacement indicator (eri) message from their deep brain stimulation (dbs) implantable pulse generator (ipg).The eri message was received, and energy use index (eui) was 2.58v six months after initial implant, as a result, the physician could not create a database analysis due to the low voltage per their assessment.It was noted the patient was a high-rate user, had a skin cancer scalp removal procedure and a wound washout at the dbs lead and burr-hole cover site (see mfr report # 3006630150-2023-04865) where bi-polar electrocautery was performed.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 implantable pulse generator (ipg) was analyzed and revealed normal characteristics during visual inspection.However, a data log analysis revealed the calculated battery lifetime was four months and 26.2 days with an average energy use index (eui) of 30.4 from the expected theoretical lifetime of one year and 12.7 days.The ipg data log also revealed a sudden battery voltage drop from 3.025 volts to 2.886 volts with a high voltage (vh) value and as a result may have (caused high impedances) which lessened the devices longevity as it maintains compliance voltage to the leads to provide stimulation, however the root cause for the vh was unable to be identified.Therefore, the engineers concluded the reported events probable cause was not established.

Event Description

It was reported that the patient received the elective replacement indicator (eri) message from their deep brain stimulation (dbs) implantable pulse generator (ipg).The eri message was received, and energy use index (eui) was 2.58v six months after initial implant, as a result, the physician could not create a database analysis due to the low voltage per their assessment.It was noted the patient was a high-rate user, had a skin cancer scalp removal procedure and a wound washout at the dbs lead and burr-hole cover site (see mfr report # 3006630150-2023-04865) where bi-polar electrocautery was performed.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: 18115877
• MDR Text Key: 327884416
• Report Number: 3006630150-2023-06948
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985020
• UDI-Public: 08714729985020
• 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: 12/29/2023

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 Expiration Date: 07/08/2023
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 205179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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 Age: 71 YR
• Patient Sex: Female