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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Discomfort (2330); Insufficient Information (4580)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 20-may-2019, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 20-may-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient presented to appointment complaining of stimulation in his rectal, perineal, groin area.The ins had been turned off for two weeks, but the patient could still feel the stimulation in the area described which has lead to an increase in bowel movements and discomfort.It was reported that the issues began after programming dtm settings.The healthcare provider (hcp) was ordering an mri to rule out other factors.The rep reviewed the stimulation usage report and noticed the stimulator was off 1/25-1/30, on from 1/30-2/8, and off again from 2/9 until current.The rep tried  reprogramming the device using different pulse width and rate.The patient could feel an increase in stimulation sensation in groin, rectal, perineal area with minor intensity increases.(.3 ma).The sensation was so strong, that he couldn't feel the stimulation in other areas.The patient has the stimulator for pain below the knees and into the feet.The rep  suggested we keep the stimulator off until the sensations go away.The hcp has also ordered and mri for further evaluation of (b)(6) spine.(b)(6), pa also has home health coming to visit (b)(6) for physical therapy.Additional information was received from the rep.It was reported that patient has macular degeneration and pain from knees to feet.In nov 2020 the patient had a device replaced with an intellis battery.Following that replacement the patient was programmed with dtm therapy and the patient was feeling intense stimulation in perineal area, groin, and rectal area.The patient has had the device off for 2-2.5 weeks and has still been feeling stimulation sensation.The caller indicated that images look like one of the leads "flipped" so the right lead is closer to the left lead now but the caller did not think that this was a significant shift or that it would cause the issue the patient was experiencing.The rep tried to program different pulse width and rate to see if the patient would feel stim in a different location but when increasing up to 0.3ma the patient was feeling strong sensation in the same perineal/groin/rectal region.The caller indicated that they plan to have the patient let the ins battery completely deplete to determine if the stimulation sensation changes.The caller indicated that the stim usage diary shows that stimulation was off.Tss reviewed therapy information and suggested following up with medical affairs.Additionally, rep stated that it began with the reprogramming of the stimulator programs, but imaging is being ordered to rule out any spine changes.Stimulation is turned off and patient is awaiting insurance approval for a mri.Patient is still feeling stimulation in the area described.So it has not resolved.Patient has began physical therapy and will be getting imaging done to further rule out other causes.

Manufacturer Narrative

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

Additional information received.Rep responded from follow up sent.Rep indicated cause was not determined.No further actions/interventions taken.Issue was resolved.

• 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
• MDR Report Key: 11385358
• MDR Text Key: 246480166
• Report Number: 3004209178-2021-03305
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 80 YR