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

Model Number 97715

Device Problem High impedance (1291)

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Swelling/ Edema (4577)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient said last week their ipg on the right side became red, swollen and enlarged.No contributing environmental, external/patient factors were noted.Patient had appointment with hcp.Hcp said ipg was not infected.Hcp said to call manufacturer.Rep will meet patient at hcp office on (b)(6) 2022 to check system/impedance.The issue was not resolved at this time.New information was received.It was reported that the cause is unknown, but suspected to be due to mechanical irritation from the battery breaking loose in the pocket causing inflammation.An allegation of ins movement in pocket and mechanical irritation were not previously reported, follow-up is being done to confirm allegations.An impedance test was performed which came back with normal results.No additional actions and interventions taken at this time, the patient will watch the site and if inflammation and pain occurs they will turn the battery off to see if the inflammation or pain dissipates, then turn it back on again to see if it returns.Pain and inflammation had not previously been reported in association with the redness and swelling at the ipg site.It is unknown if the issue has been resolved, but the patient reports that the inflammation had gone down quite a bit already, and the hcp will be informed if the symptoms continue to be an issue.It was reported that an impedance test indicated that two of the electrodes on the patient's quad lead are in the orange.It¿s hard to tell whether it¿s the lead or the extension that¿s the problem.For some reason the intellis controller was no longer paired to her battery.This was easily fixed by reestablishing connection.The programming being used was not utilizing the effective electrodes.Pt is going to try the programming to see if it provides effective therapy.Unknown if issue is resolved.Information was received from a rep that prior statements about the cause of the redness and swelling at the ipg site were speculation and not a confirmation of an allegation, and the cause of the issue still remains unknown.New information was received from the rep that the reprogramming improved coverage for the patient's legs.Additional information was reported that the patient's pocket revision was completed today.The battery was moved about 3 inches laterally in her abdomen.A seroma was observed the doctor at the old battery site.The area looked infected so the doctor sent specimens to lab for analysis.Unfortunately those labs come back positive and the system will likely be removed.

Manufacturer Narrative

Continuation of d10: product id 3487a-33 lot# j0343786v serial# implanted: (b)(6) 2004.Explanted: product type lead medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Infection was not confirmed.Surgery was performed to evacuate the seroma on (b)(6) 2022.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14983376
• MDR Text Key: 295675640
• Report Number: 3004209178-2022-08762
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

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: 09/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/15/2022
• Date Device Manufactured: 10/01/2020
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female