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); Charging Problem (2892)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/14/2019

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 consumer who was implanted with an implantable neurostimulator (ins).The patient reported that since implant she has had tons of pain at the ins site, it hurts constantly.The patient has told the healthcare provider (hcp) and the hcp told her to wear the binder more.The pain almost took her to the floor the other day it hurt so bad.The patient will go back to clinic because the patient wants them to look in the ins site to see why she is having so much pain.The whole area where the battery is located hurts.The patient also stated charging duration issues.Since implant she has had nothing but problems with the implant needing to be charged every 5 hours, then the rep, got it to every 6 hours, then they put it on bursts and she can go for 23 to 24 hours.Additional information received from the patient on (b)(6( 2021.It was reported that the patient had different issues when trying to recharge their implantable neurostimulator (ins) and due to these issues their ins charge time varied greatly.When the patient charged their ins sometimes they lost connection very easily (without moving) and they received the "poor recharge quality" message.The controller screen at times went blank or black or white.The patient received a screen that counted down and they received a "software problem" message (the patient didn't know specific codes).The patient reset their controller to clear all these s creens/messages.The patient used their belt when they charged their ins.They denied any damage on the recharger telemetry module (rtm) or in the controller port except the rubber on the cord where it entered the coil looked lighter.The issue was not resolved through troubleshooting.A replacement device was requested.The patient mentioned they had pain at their ins implant site.This was due to the ins moving up so on (b)(6) 2021the patient was having the ins moved lower.The patient said that it hurt to walk or bend due to where the ins was currently positioned.No further complications reported.

• 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: 11361126
• MDR Text Key: 234433094
• Report Number: 3004209178-2021-02995
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Date Device Manufactured: 04/24/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 48 YR