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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Erythema (1840); Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Date 06/08/2022

Event Type  Injury  

Event Description

Patient (b)(6) had bilateral stn-dbs surgery on (b)(6) 2022 for treatment of parkinson's disease.On (b)(6) 2022 evening the patient noticed redness and drainage from the right parietal incision and the study clinician was notified on (b)(6) 2022.The clinician has determined this is a hardware infection of right-sided system, one month after implantation.The patient is scheduled to have his right sided hardware removed on (b)(6) 2022.The current plan is to re-implant his right sided hardware in (b)(6) 2022, after everything has healed well.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; minneapolis MN
• MDR Report Key: 14712438
• MDR Text Key: 294380897
• Report Number: MW5110357
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic