MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE GENUS R16; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB1216

Device Problems Computer Software Problem (1112); Environmental Compatibility Problem (2929)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Patient has a boston scientific vercise genus r16 (db1216) placed (b)(6) 2021 for parkinson disease.Patient recently purchased a whill model ci2 motorized wheelchair.Upon first use of the chair, her dbs system appears to have tripped to another, older, program.She contacted writer's office and was stabilized, but issue recurred over weekend repeatedly.Exact circumstances uncertain but perhaps correlated with several bluetooth emitting / emi devices including a laptop, tablet and cellphone.Currently we are investigating further to localize source and reproduce events.Fda safety report id# (b)(4).

• Brand Name: VERCISE GENUS R16
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• MDR Report Key: 14021743
• MDR Text Key: 288820157
• Report Number: MW5108794
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2022

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 Model Number: DB1216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CELL PHONE; LAPTOP ; WHILL MODEL CI2 MOTORIZED WHEELCHAIR
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White