MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97725

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Complaint, Ill-Defined (2331); Nipple Ulceration (2441); Skin Inflammation (2443); Alteration In Body Temperature (2682); Fluid Discharge (2686); Test Result (2695)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 06-jun-2022, udi#: (b)(4).Initial reporter's occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturing representative (rep) regarding a patient with an external neuro stimulator (ens).It was reported that patient had possible infection.Lead was removed at hospital er.Patient has psoriasis and sterile coverage/ bandage kept falling off that may have led or contributed to the issue.Patient was admitted to hospital.Lead pulled at hospital and patient admitted.Rep indicated to contact health care professional (hcp) for further information.Rep further explained that during a mid-trial phone follow up patient stated he may have an infection, said it was red and warm at the lead sight butnotiozing and no fever.Rep instructed patient go to the er if he felt it was and patient told rep he would think about it.Patient made a comment that he could lance it.Rep told him he needed to go to the er.Patient called the health care professional (hcp) the next morning and hcp told him to come in.Patient said he did not want to drive.Hcp prescribed antibiotic keflex which he took one dose of.That night rep was notified that patient went to the er and was admitted with fever, oozing from lead site and elevated white count.Lead was removed and patient was being treated at hospital.No further patient symptoms or complications were reported in this event.

Manufacturer Narrative

Other applicable components are: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: screening device.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the representative.It was reported that the patient hadn't responded to the clinic yet so they didn't know if the patient's symptoms resolved but they had an upcoming appointment at the clinic.No further complications reported.

Manufacturer Narrative

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

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7707895
• MDR Text Key: 114671236
• Report Number: 3007566237-2018-02176
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• 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
• Report Date: 10/04/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 07/31/2018; 08/08/2018
• Supplement Dates FDA Received: 08/06/2018; 10/04/2018
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 118