MAUDE Adverse Event Report: MEDTRONIC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) of a clinical study regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported the patient had worsening hand movements bilaterally about a week after the initial programming visit.The pi felt that it could be due to the stimulation unmasking more dystonia.The patient's mother was instructed to go up on the voltage slowly.This has been an ongoing issue that fluctuates in severity, but for the most part it has remained stable with the exception of the appointment on (b)(6) 2018, where the patient's mother reported the patient had a sudden worsening of the patient's arm movements.Due to the sudden onset of these symptoms, the pi felt that this episode of worsening symptom was likely not related to the study procedures.This issue was ongoing, but stable.The pi recommended a dental consultation and ordered uti and yeast infection cultures to rule out other possible causes.This was mild and possibly related to the study procedures.No further complications were reported as a result of this event.

• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC; sullivan lake
• Manufacturer (Section G): MEDTRONIC; sullivan lake
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7557598
• MDR Text Key: 109762448
• Report Number: 3007566237-2018-01648
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2018
• 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