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

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Alteration In Body Temperature (2682)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer's representative and a consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient was experiencing tenderness and redness at the battery site.An impedance test was performed and all values were consistent with or and post-op testing.The patient was going to see a surgeon and it was unknown if surgical intervention was planned.Additional information received from a manufacturer's representative on 2019-feb-20.It was reported that the physician prescribed antibiotics for the patient and it was unknown if the issue was resolved.No further complications 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 a manufacturer¿s representative (rep).The rep reported that the patient was suspected of having a post-operative infection.The system was explanted and the wound was cultured.The rep noted that the hospital was in possession of the device and it would be sent back when it was released.The rep reported that the patient was placed on antibiotics and had since recovered.The issue was resolved.No further complications were reported.[refer to (b)(4) for information pertaining to ins not functioning, replaced].

Manufacturer Narrative

Product id 977a260, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2019, product type: lead.Analysis of the implantable neurostimulator found that there was no anomaly of the device.Analysis of the lead with serial number (b)(4) found that all conductors were broken 20.5 centimeters from the distal end, conductor #10 was broken 2.9 centimeters from the proximal end, and the setscrew impression was too proximal.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up will be submitted when analysis is complete.Conclusion codes, method/ result longer apply.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the ins serial# (b)(4) was not performed as the event pertained to a non-analyzable medical issue (and not a device issue).The conclusion code was updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the ins was infected and the patient had a fever, redness, swelling and pain.The patient also mentioned burning, hot to the touch, not feeling well and thought they were getting a cold.The patient stated they went to the healthcare professional's (hcp) office and they did programming for the adaptive stimulation (as) and 30 minutes later "it started acting up" and the patient was sick.The patient clarified they started feeling a burning pain in the ins implant site pocket.The patient stated when they got into their car the pressure from the seat pressing on the ins site "hurt really bad".The patient said they went to work and then got a fever and they weren't feeling well, like they were getting a cold.The patient said they had the fever for 4 days and they were freezing.The patient stated the ins implant site was burning and they could feel the outline of the ins like it was inflamed and burning and the surrounding tissue and was very hot to the touch.The patient said the ins implant site was swollen, inflamed and burning and so was the incision site.The patient thought the activation of as may have triggered the infection.The patient said the infection was confirmed and they were told what type of infection but they were still studying the cultures.The patient said they were admitted to the hospital on (b)(6) 2019 and released on (b)(6) 2019.The patient said they were given iv and oral antibiotics and the full system was explanted (b)(6) 2019.The patient stated they had a follow-up appointment with the hcp yesterday, and the hcp said the patient was healing well.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: 8371660
• MDR Text Key: 137193226
• Report Number: 3004209178-2019-04041
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 46 YR