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

Model Number DB-1216

Device Problem Wireless Communication Problem (3283)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that the deep brain stimulation (dbs) patient was having difficulty connecting to the implantable pulse generator (ipg).The patient underwent a replacement of the ipg.There were no reported complications stemming from the replacement procedure.

Manufacturer Narrative

The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.No problem was detected with the ipg.

Event Description

It was reported that the deep brain stimulation (dbs) patient was having difficulty connecting to the implantable pulse generator (ipg).The patient underwent a replacement of the ipg.There were no reported complications stemming from the replacement procedure.

Manufacturer Narrative

The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.No problem was detected with the ipg.

Event Description

It was reported that the deep brain stimulation (dbs) patient was having difficulty connecting to the implantable pulse generator (ipg).The patient underwent a replacement of the ipg.There were no reported complications stemming from the replacement procedure.The referenced ipg was returned for laboratory analysis in the sealed sterile pouch is was originally packaged in, indicating that the device had never been implanted.Further review of the information reported from the field confirmed that the communication difficulty occurred prior to implantation during preparation for the procedure.The patients implant procedure was successfully completed using a different ipg.

• 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: 17944775
• MDR Text Key: 325797996
• Report Number: 3006630150-2023-06280
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/19/2024

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: Health Professional
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 559008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 01/19/2024; 03/05/2024
• Supplement Dates FDA Received: 02/07/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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