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

Model Number 97715

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Overheating of Device (1437)

Patient Problems Undesired Nerve Stimulation (1980); Swelling (2091); Burning Sensation (2146)

Event Date 04/05/2018

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 consumer via a manufacturer representative regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the implant site felt hot and it was also from the middle of their back down to their groin.This occurred the day before the report (b)(6) 2018.The therapy was turned on earlier yesterday but they felt it later in the evening.It was reported that the patient did not appear to have symptoms when therapy was off.Impedances were not checked at the time of the report.The manufacturer representative was going to meet with the patient next monday to check the system.Additional information was received from the manufacturer representative on (b)(6) 2018 when they were with the patient.Impedances were fine with a range around 780-1350 ohms while checking different reference electrodes.The patient did sometimes fell stimulation when the ins was off.The ins started feeling hot after it had been on for about 30 minutes.This was confirmed in the office when the ins had been on for about 25 minutes when the manufacturer representative had to turn the ins off since the patient began to feel the sensation.When the ins was turned on, the patient felt stimulation appropriately.The patient indicated that the sensation felt like post-op pain from when the ins was first replaced.The patient had not noticed any redness or swelling at the ins site beyond swelling right after replacement.The incision was examined by the hcp last thursday and no issues were said to be found.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative on 2018-apr-11 reporting that the patient turned stimulation off once they could no longer tolerate the sensation at the battery site.The cause had not been determined at this time.The patient would be making an appointment in the future with the manufacturer representative.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient via manufacturer's representative.It was reported patient felt burning sensation at stimulator pocket site and got very hot when patient turned ins on.It was reported the burning sensation started increasing 10 minutes after ins was on.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep) reporting that the rep was unsure at this time if any further actions/interventions would be taken to resolve the patient¿s burning sensation at the ins site.The patient was rescheduling to see their healthcare provider (hcp) to discuss this, but the appointment date was unknown at this time.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/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: 7420299
• MDR Text Key: 105374951
• Report Number: 3004209178-2018-07754
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/05/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 04/11/2018; 10/16/2018; 10/24/2018
• Supplement Dates FDA Received: 04/19/2018; 10/18/2018; 11/05/2018
• Date Device Manufactured: 02/20/2018
• 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
• Patient Age: 52 YR