MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problem Pocket Stimulation (1463)

Patient Problems Itching Sensation (1943); Burning Sensation (2146)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that everything was going well since implant and during the night of (b)(6) 2021 to (b)(6) 2021, the patient felt a discharge from his ins.Since then he has felt a burning sensation and an internal itching sensation at the level of the stimulator.On (b)(6) 2021, the patient called the clinic which advised him to switch off the ins.He no longer felt any itching.He was seen on (b)(6) 2021 in consultation, the doctor turned the ins back on and the itching returned.It was unknown if there were any contributing factors.Troubleshooting/diagnostics were performed.Impedance tested okay, connectivity test okay, no drop/fall reported, no new device that could interfere with the stimulation.A radiological/x-ray examination of the ins will be done.The issue was not resolved at the time of this report.The patient was alive with no injury.Additional information was received reporting no abnormality detected on radiology.The electrodes were well behind the ins.The cause was not determined.A revision surgery will be planned to see what happened but not date set yet.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11802532
• MDR Text Key: 262206970
• Report Number: 3004209178-2021-07496
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2021
• Date Device Manufactured: 01/15/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR