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

Model Number DB-1140

Device Problems Premature Discharge of Battery (1057); Unexpected Therapeutic Results (1631)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  Injury  

Event Description

It was reported that the patients ipg, implantable pulse generator, battery depleted prematurely.The patient underwent a procedure in which the ipg was replaced.

Event Description

It was reported that the patients ipg, implantable pulse generator, battery depleted prematurely.The patient underwent a procedure in which the ipg was replaced.It was additionally reported that the patient experienced inadequate stimulation causing the return of their symptoms.Reprogramming was attempted but was unsuccessful.The device will be returned for analysis.

Manufacturer Narrative

Device technical analysis: the ipg, implantable pulse generator, was in service for about three months with an energy use index (eui) range of 24.6, and the expected range would be about 20 months per the direction for use.The patient's data also shows a sudden battery drop at the time of the implant procedure, from 2.999 volts to 2.873 volts.The incident shortened the device's longevity significantly.Lab analysis of the device did not reveal any anomalies.Labeling review: a labeling review was performed on the implantable pulse generator, ipg, instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Investigation conclusion: based on all available information, engineers are not able to confirm the root cause of the event.The ipg was returned and analyzed, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint and the conclusion is cause not established.

Event Description

It was reported that the patients ipg, implantable pulse generator, battery depleted prematurely.The patient underwent a procedure in which the ipg was replaced.It was additionally reported that the patient had experienced inadequate stimulation causing the return of their symptoms prior to the revision proedure, and that reprogramming was attempted but was unsuccessful.

• Brand Name: VERCISE PC
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12685693
• MDR Text Key: 278092837
• Report Number: 3006630150-2021-05941
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P150031
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2023
• Device Model Number: DB-1140
• Device Catalogue Number: DB-1140
• Device Lot Number: 633474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• 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