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

Model Number DB-1216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Incontinence (4572)

Event Date 09/21/2021

Event Type  Injury  

Event Description

It was reported that the patient, that is enrolled in the (b)(6) clinical trial, experienced a serious adverse event of urge incontinence which was mild in severity.The patient was given medication and was hospitalized.The event resolved a week and a half later.The event was assessed as not related to the procedure or the device itself.The event was assessed as having a possible relationship to the stimulation.

Event Description

It was reported that the patient, that is enrolled in the a4012 clinical trial, experienced a serious adverse event of urge incontinence which was mild in severity.The patient was given medication and was hospitalized.The event resolved a week and a half later.The event was assessed as not related to the procedure or the device itself.The event was assessed as having a possible relationship to the stimulation.Additional information was received that the relationship to the stimulation was updated to unlikely.Database analysis was completed and confirmed that the device is operating as expected.

Event Description

It was reported that the patient, that is enrolled in the a4012 clinical trial, experienced a serious adverse event of urge incontinence which was mild in severity.The patient was given medication and was hospitalized.The event resolved a week and a half later.The event was assessed as not related to the procedure or the device itself.The event was assessed as having a possible relationship to the stimulation.Additional information was received that the relationship to the stimulation was updated to unlikely.Database analysis was completed and confirmed that the device is operating as expected.Additional information was received stating that the event was updated to indicate that the relationship to procedure was reported as possible.

• 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: 12734389
• MDR Text Key: 279517720
• Report Number: 3006630150-2021-06141
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/10/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 511159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 02/25/2022
• Supplement Dates FDA Received: 01/12/2022; 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male