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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problem Device Overstimulation of Tissue (1991)

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 patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was white electronic device on one side of the chair and he asked pt if they could feel stimulation and at first pt could not feel it.Then the rep moved it on the left hand side and asked pt if they could feel it and pt said a little, but that they didn't feel it up into their back.Pt stated that the rep then spoke with pt's physician and they want to explant the implant.Later in the conversation, pt mentioned that they could feel the stimulation strong in their back as if there was a sign of a cross on their back.Pt also mentioned that (b)(4) told pt not to increase their stimulation.Patient services (ps) attempted to clarify events and dates but due to the nature of the caller, was unable to do so.Each time ps would attempt to clarify something, pt would start talking about something else.Pt also mentioned working with mdt rep, (b)(4).Ps attempted to clarify which events pt reported to which reps and pt was unable to confirm.Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported that they are unable to check the position with their controller.Pt confirmed that they were reprogrammed yesterday and was told not to adjust/increase stimulation.Pt mentioned that they already spoke with mdt rep, (b)(4) directed them to call patient services (ps).Ps redirected pt back to their physician/mdt rep for further direction being that they were just instructed not to adjust settings.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from a manufacturer's representative (rep).The rep reported that adaptive stimulation was not enabled.The rep reported that the patient confuses pain in her back with stimulation.The physician has explained to her the difference and has suggest an explant.The physician is planning to explant the ins, no date scheduled yet.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11872869
• MDR Text Key: 252296900
• Report Number: 3004209178-2021-08228
• 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
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Date Device Manufactured: 04/14/2020
• 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
• Patient Outcome(s): Required Intervention