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

Model Number DB-1416

Device Problems Premature Discharge of Battery (1057); Inadequate or Insufficient Training (1643)

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

It was reported the patient experienced premature battery depletion.A report from the field indicated the patient's implantable pulse generator (ipg) was nearing end of life after thirteen months of use.Analysis of the ipg settings and stimulation usage by engineers revealed an energy use index (eui) index of 10.2 with impedances within normal range; indicating an anticipated approximate 36 months of service.Further review of the battery voltages for the ipg revealed an unexpected drop at the time of implant and a more than usual decline in voltage over the thirteen months of service.No further information has been provided despite good faith efforts.

Event Description

It was reported the patient experienced premature battery depletion.A report from the field indicated the patient's implantable pulse generator (ipg) was nearing end of life after thirteen months of use.Analysis of the ipg settings and stimulation usage by engineers revealed an energy use index (eui) index of 10.2 with impedances within normal range; indicating an anticipated approximate 36 months of service.Further review of the battery voltages for the ipg revealed an unexpected drop at the time of implant and a more than usual decline in voltage over the thirteen months of service.No further information has been provided despite good faith efforts.Additional information was received that the patient underwent an explant procedure wherein the ipg was explanted.The patient was doing well postoperatively.

Event Description

It was reported the patient experienced premature battery depletion.A report from the field indicated the patient's implantable pulse generator (ipg) was nearing end of life after thirteen months of use.Analysis of the ipg settings and stimulation usage by engineers revealed an energy use index (eui) index of 10.2 with impedances within normal range; indicating an anticipated approximate 36 months of service.Further review of the battery voltages for the ipg revealed an unexpected drop at the time of implant and a more than usual decline in voltage over the thirteen months of service.No further information has been provided despite good faith efforts.Additional information was received that the patient underwent an explant procedure wherein the ipg was explanted.The patient was doing well postoperatively.

Manufacturer Narrative

Device analysis performed on the returned ipg revealed the primary cell battery reached the end of service (eos) mode prematurely after 13 months of use.Engineers determined that there was a sudden drop in battery voltage at the time of implant which resulted in early ipg battery depletion and shortened the device longevity.Observations from the field indicated that the ipg had not been exposed to magnetic resonance imaging (mri) or any other high energy exposures during implant or shortly after.The cause of the voltage drop could not be determined as no anomalies were found through laboratory analysis.Based on all the available information, the cause of the reported event could not be established.

• 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: 15339807
• MDR Text Key: 299167843
• Report Number: 3006630150-2022-04436
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985020
• UDI-Public: 08714729985020
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/15/2022

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: 02/19/2023
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 202840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 10/11/2022; 12/07/2022
• Supplement Dates FDA Received: 11/04/2022; 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male