MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC SUMMIT RC+S; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Device Problem Output Problem (3005)

Patient Problems Nausea (1970); Vomiting (2144); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/30/2021

Event Type  Injury  

Event Description

Patient (b)(6) had bilateral gpi dbs surgery on (b)(6) 2021 for treatment of longstanding severe cervical dystonia and was discharged to home on (b)(6) 2021 (2 days post operation).On (b)(6) the patient reported since discharged to home he has had nausea and vomiting exacerbated by any movement, by talking, or by standing up, persisted through (b)(6) with no relief from zofran, and only partial relief from ativan.The study neurosurgeon recommended an er visit for hydration/electrolyte check/nausea management.His electrolytes were normal, ct showed some residual intracranial air as expected.He responded well to iv hydration, with reduced nausea, was able to eat was discharged after < 24 hour stay.The patient reported complete recover and sae was resolved on (b)(6) without further sequelae.Status post bilateral deep brain stimulator and electrode implantation.Given the limitation of study due to artifacts, no definite acute intracranial hemorrhage, hydrocephalus, or herniation.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC SUMMIT RC+S
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 12313686
• MDR Text Key: 267646074
• Report Number: MW5103215
• Device Sequence Number: 1
• Product Code: MHY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 69