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

Model Number DB-1416

Device Problem Premature Discharge of Battery (1057)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported the patient's deep brain stimulation (dbs) implantable pulse generator (ipg) was depleted after six months of use.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.

Manufacturer Narrative

Approximated based on the report that the patient had been implanted for six months.

Event Description

It was reported the patient's deep brain stimulation (dbs) implantable pulse generator (ipg) was depleted after six months of use.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.

Event Description

It was reported the patient's deep brain stimulation (dbs) implantable pulse generator (ipg) was depleted after six months of use.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.

Manufacturer Narrative

Analysis of the returned ipg revealed the primary cell battery had prematurely depleted after 202 days of use.Based on the average energy use index (eui) of 9.6, the estimated lifetime for the ipg would have been approximately 3 years.The battery longevity was significantly reduced due to a sudden battery drop from 2.907 volts to 2.830 volts.Analysis of the device by engineers did not reveal any anomalies, and the root cause of the sudden battery drop could not be determined.

• 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: 15629821
• MDR Text Key: 303442974
• Report Number: 3006630150-2022-05620
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985020
• UDI-Public: 08714729985020
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

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: 09/28/2023
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 206465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 12/22/2022
• Supplement Dates FDA Received: 12/15/2022; 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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