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

Model Number DB-1200

Device Problems Use of Device Problem (1670); Wireless Communication Problem (3283)

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

Event Date 12/14/2022

Event Type  Injury  

Event Description

It was reported that following a previous revision procedure in which a plasma blade system was used it was not possible to connect the patient's implantable pulse generator (ipg) to the clinician programmer (cp).Multiple charging sessions were made and multiple cp's were utilized but it did not resolve the connectivity issue.The patient underwent a revision procedure in which the ipg was replaced.The ipg was turned on and programmed following the revision, and the patient was able to receive therapy and is doing well post operatively.

Manufacturer Narrative

The device was returned, analyzed and it was undetectable to a known good remote control or clinical programmer and would not charge.The internal battery measured 1.39 volts and the electrical test revealed that the application specific integrated circuit (asic) was damaged with excessive quiescent current and low resistance across voltage high (vh) node.Thermal imaging confirmed a high thermal spot.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 as having been the unintended use error caused or contributed to event.

Event Description

It was reported that following a previous revision procedure in which a plasma blade system was used it was not possible to connect the patient's implantable pulse generator (ipg) to the clinician programmer (cp).Multiple charging sessions were made and multiple cp's were utilized but it did not resolve the connectivity issue.The patient underwent a revision procedure in which the ipg was replaced.The ipg was turned on and programmed following the revision, and the patient was able to receive therapy and is doing well post operatively.

• Brand Name: VERCISE GEVIA
• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16225359
• MDR Text Key: 307917710
• Report Number: 3006630150-2023-00176
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 748392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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
• Patient Sex: Male