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

Model Number 97715

Device Problem Overheating of Device (1437)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Burning Sensation (2146); Tingling (2171)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for complex regional pain syndrome (crps).It was reported that the patient had a thermal sensation and pain due to generation of heat at the ins site.Pain and generation of heat were observed from the abdomen of the ins implantation site to the connection place of the lead, and internal bleeding was observed as well.The issue was resolved after turning off the stimulation, but generation of heat occurred after turning the stimulation on.The generation of heat was also confirmed by palpation by the physician.On (b)(6) 2019, the stimulation was delivered normally and the impedance was normal.Device settings were noted as 1.5 milliamperes amplitude, 90 microseconds pulse width, 1000 hertz rate, impedance around 1000 ohms, bipolar stimulation with electrodes 3 and 11 used as anodes and electrode 4 used as a cathode, and 24 hours per day usage.X-ray images were not available.Telemetry data was available.There were no particular environmental/external/patient factors that may have led or contributed to the issue.The issue was not resolved as of (b)(6) 2019.No surgical intervention occurred, and it was unknown if surgical intervention was planned.It was noted that the physician's observation about severity was not severe, and their observation about causality was unknown.The patient was alive with injury.Additional information was received from the rep.It was reported that an impedance check was performed together with the physician and the normal value was confirmed.The thermal sensation and pain in the abdomen were increased after turning on the stimulation, but it was assumed that there was a high possibility that the abdomen responded to the effect of stimulation.It was confirmed that there was also a tingling feeling in the abdomen when stimulation was delivered.The stimulation would be turned off until the inflammation of the abdomen was cured and then stimulation would be resumed on (b)(6) 2019.

Manufacturer Narrative

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

Event Description

Additional information received reported that when the stimulator was turned off, the issue was settled down.The hcp noted that ¿there was a possibility that the inflammation site had a stimulus-induced fever.¿ the stimulator was off at the time of follow-up and it was planned not to turn the ins on until the inflammation was completely settled.It was noted that there was no abnormality in the range which could be understood with the clinician tablet and that resistance values were normal.As a result, it was stated that ¿the possibility of the malfunction of the stimulation device can be denied.¿ the patient¿s physician was reportedly ¿convinced that the symptom was caused by the stimulation to the inflamed part.¿ no further complications were reported or anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8679887
• MDR Text Key: 147380537
• Report Number: 3004209178-2019-11162
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Date Device Manufactured: 10/10/2018
• 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