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

Model Number DB-1200

Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892)

Patient Problem Movement Disorder (4412)

Event Date 10/05/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced difficulty charging their implantable pulse generator (ipg).The patient was admitted to the hospital and it was discovered that the ipg was depleted which caused the ipg to switch off and therefore the patient experienced a loss of stimulation which resulted in a return in their parkinsons disease symptoms.The patient was re-educated on how to properly charge their ipg.The patient was then able to successfully charge their ipg and was discharged from the hospital.

Manufacturer Narrative

A database analysis was performed and there were no anomalies found in the battery discharge logs therefore the root cause of the charging issue could not be determined.

Event Description

It was reported that the patient experienced difficulty charging their implantable pulse generator (ipg).The patient was admitted to the hospital and it was discovered that the ipg was depleted which caused the ipg to switch off and therefore the patient experienced a loss of stimulation which resulted in a return in their parkinsons disease symptoms.The patient was re-educated on how to properly charge their ipg.The patient was then able to successfully charge their ipg and was discharged from the hospital.

• 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: 18178817
• MDR Text Key: 328611857
• Report Number: 3006630150-2023-07212
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2022
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 744193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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): Hospitalization