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

Device Problem Material Separation (1562)

Patient Problems Purulent Discharge (1812); Staphylococcus Aureus (2058)

Event Date 11/29/2020

Event Type  Injury  

Event Description

Patient rcs12 had bilateral stn-dbs with cortical sensors and bilateral rc+s ipgs implanted on (b)(6) 2020 for treatment of parkinson's disease.On (b)(6) 2020 the study clinicians noted some scab formation around right frontal incision and started antibiotic (keflex) treatment.Several days later the patient has noticed yellowish drainage from right frontal incision.The study neurosurgeon saw the patient on (b)(6) 2020 and noted that the medial part of the right frontal incision was slightly separated and purulent.This is directly over the burr hole cap and thus likely communicates with the cap.All other incisions appeared well healed and neurologically the patient was back to pre-surgical baseline.From both history and exam, this appeared to be a dbs hardware infection over the right burr hole cap.Thus removal of right sided hardware was indicated, and should be done to avoid intracranial spread of infection.All hardware on the right side was completely removed on (b)(6) 2020 with no complication noted.Additional details and updates provided by the study pi and neurosurgeon (on 12/20) indicates culture results show: -frontal incision hardware grew staph epidermidis and c.Acnes -parietal incision hardware grew c.Acnes -brain leads were sterile suggesting no intracranial extension additionally, the surgeon removed a long-standing 1 cm scalp lesion that was near the region of the lead extenders, which was cystic and also grew c.Acnes.It is possible that the infection spread from this cyst, which had been present for years (mobile painless 1 cm lump in his scalp) prior to the dbs surgery.The patient is on 4 weeks iv vancomycin (antibiotics) which should treat both organisms, and is doing well.Our irb completed the review of this sae with the outcome of "not an unanticipated problem - no action required".Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC SUMMIT RC+S
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION ; minneapolis
• MDR Report Key: 11071906
• MDR Text Key: 223737344
• Report Number: MW5098516
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): Y
• 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: 12/22/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73