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

Model Number DB-1216

Device Problems Device Displays Incorrect Message (2591); Wireless Communication Problem (3283)

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

Event Date 11/25/2021

Event Type  Injury  

Event Description

It was reported that three days following the implant procedure the patient experienced communication errors with the ipg, implantable pulse generator.Several attempts to link the ipg to the patients rc, remote control, were made but were unsuccessful.The rc was replaced but the new rc also did not connect to the ipg.The patient underwent an a revision procedure in which the ipg was replaced.The patient is doing well post operatively.The device has been received but analysis has not been completed.

Manufacturer Narrative

Correction to field d8: serviced by 3rd party.The returned ipg was undetectable nor charged.The ipg was cut open and the battery voltage was measured at 3.374 volts despite several charging attempts due to excessive current leak (235 ua).After installing a substitute battery the device data was captured and the functional test was performed and it passed.The patient data showed that the device had been working normally with a battery depletion rate of 6.59 mv until timestamp 17434664 where high vh (high voltage) values and the battery plunged at once and was never recovered.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.Based on all available information, engineers are able to confirm the root cause of the event, of the patient experiencing communication errors with the ipg, implantable pulse generator as unintended use error caused or contributed to event.

Event Description

It was reported that three days following the implant procedure the patient experienced communication errors with the ipg, implantable pulse generator.Several attempts to link the ipg to the patients rc, remote control, were made but were unsuccessful.The rc was replaced but the new rc also did not connect to the ipg.The patient underwent a revision procedure in which the ipg was replaced.The patient is doing well post operatively.Analysis of the device of the ipg has been completed.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13070620
• MDR Text Key: 282702090
• Report Number: 3006630150-2021-07195
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/29/2022

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: 11/24/2022
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 502351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• 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 Sex: Female