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

Model Number 97715

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Note: this regulatory report references and is related to regulatory report 3004209178-2021-06506.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 about three (3) weeks after the pump was implanted, pt started to get withdrawal-like symptoms.Pt reported she has been working with her pump managing health care provider (hcp) and he has made slight dose adjustments.Pt reported after the increase, pt was still experiencing the withdrawal-like symptoms so pt decided to test out why that was occurring since she also has a neurostimulator.Pt reported after about two (2) weeks of experimenting with programming her neurostimulator, pt reported that when she had her neurostimulator up to her normal programming, about two (2) hrs in pt will start to experience withdrawal-like symptoms.Pt reported she tried programming her neurostimulator at a really low setting, about 3-4 hrs in she will start to feel the withdrawal-like symptoms.Pt reported she tried turning the neurostimulator completely off and she doesn't have the withdrawal-like symptoms therefore leads pt to believe it is an interaction between the most current pump and the neurostimulator.Pt reported the previous pump did not have an issue with the neurostimulator and it was only until the pt got the new pump.Pt confirmed the drugs in the pump have all been the same and the only difference is the increase in dose.Pt reported she is afraid to increase her dosing any more since one of the medication is a numbing agent and when she gives herself a bolus it will sometimes numb her legs (pt stated this has been happening for years and is related to the numbing drug).Pt reported she has the pump in her left abdomen and the stimulator in her right back.Patient services (pss) redirected to hcp to further address and warm transferred pt to stim ps.Third medication is naropin.Pt mentioned she does not have a managing hcp for her neurostimulator and has worked with reps kit and (b)(6) in the past for programming.The ins and pump have been fighting ever since the patient got their new pump.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11808436
• MDR Text Key: 251498182
• Report Number: 3004209178-2021-07562
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Date Device Manufactured: 06/25/2019
• 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 Age: 54 YR