MAUDE Adverse Event Report: ST. JUDE UNKNOWN STIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL TREMOR

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Shaking/Tremors (2515); Movement Disorder (4412)

Event Type  Injury  

Event Description

It was reported in an article (marotta, g., roothans, j., astrom, m., musacchio, t., lopiano, l., lanotte, m., lehrke, r., buck, a.K., volkmann, j., isaias, i.U.Brain: a journal of neurology.2016.Doi:10.1093/brain/aww223) that one st.Jude patient with bilateral deep brain stimulation (dbs) of the subthalamic area for treatment of essential tremor (et) experienced secondary dbs failure characterized mainly by chronic-progressive gait ataxia.After an initial benefit on tremor without any side effect, these patients showed a progressive decline in dbs efficacy, beginning >3 months after initial programming.The patients needed repeated stimulation adjustments to compensate for the reduced tremor control.Subsequently, they developed a chronic-progressive gait ataxia, in absence of any other dbs-related adverse event, over a period of at least four weeks of chronic stimulation with unchanged settings.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL TREMOR
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17536143
• MDR Text Key: 321068117
• Report Number: MW5143033
• Device Sequence Number: 1
• Product Code: PJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1