MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION RC+S IPG; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/24/2021

Event Type  Injury  

Event Description

Patient (b)(6) with cervical dystonia was implanted with bilateral pallidal dbs and a right chest rc+s ipg about one year ago (leads were placed (b)(6) 2020 and ipg implanted (b)(6) 2020) and recovered very well.On (b)(6) 2021 (one year later) he noted yellow drainage from a small opening in right parietal area and came in to er.The opening was over one of the dbs leads where it inserted into the lead extender.He had no pain or tenderness or erythema, and no systemic signs.The study pi became aware of this event on (b)(6) 2021 and scheduled a procedure to remove all the hardware on (b)(6) 2021, also noted there was cloudy yellow fluid around the ipg.The distal lead extenders/proximal connectors were sent for culture.Infection is an expected risk for all dbs surgeries, and is already listed on the consent form on page 10: "if you are having both sides of the brain treated, you will need two pulse generators implanted, and will not have the choice to have only one.Because of this, you may have a slightly increased risk of postoperative pain; infection due to an additional surgical site; and an additional surgical scar on the chest." fda safety report id#: (b)(4).

• Brand Name: RC+S IPG
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; minneapolis MN
• MDR Report Key: 13224989
• MDR Text Key: 283781425
• Report Number: MW5106570
• Device Sequence Number: 2
• Product Code: MRU
• 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: 01/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: 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: 64 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic