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

Model Number 97715

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Low impedance (2285)

Patient Problems Device Overstimulation of Tissue (1991); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3778-45, serial#: (b)(4), product type: lead.Product id: 3778-45, serial#: (b)(4), product type lead.Product id: 3778-45, serial/lot #: (b)(4), ubd: 08-may-2013, udi#: (b)(4).Product id: 3778-45, serial/lot #: (b)(4), ubd: 08-may-2013, udi#: (b)(4).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.Patient reports about a month ago she had a fall.She sleeps in a twin bed and she was having a dream and rolled out of the twin bed and landed on the floor.She thinks she landed on the side.She did not hurt herself but after that fall her settings were not working.She usually could run intensity around 4 and it would be fine, she could feel it in her legs and where stim is supposed to be.Ever since the fall she has to turn up the intensity to like 7 to feel any stim.In the past if she went up to 7 stim would feel very strong and it would make her stomach jump.Now she can barely feel stim at 7.Pt also reports in the past she could arch and feel stim strong but now she does not feel stim when she arches.Pt says she reset her ptm and it did not resolve it.Pt saw her surgeon the other day and he told her to call the manufacturer.It is recommended to have a device checked after any fall.Redirected to hcp.It was asked if pt has other groups to try.Pt says she has group a but she does not use group a because it is set so high so that when she uses it, it makes her stomach jump.On the call pt tried a different group.It was at 6 and she says she feels stim all the way up in her rib.If she is going to use this setting, it will make her ribs jump.Pt also mentioned she has an hcp apt on monday with a pain psychologist.Additional information was received from the patient and it was reported that the implant hadn't been acting the way it should be for about a month to a month and a half.Patient said she hasn't had the device programmed yet and was looking for a programming apt with a manufacturing representative (rep).Troubleshooting was unable to be performed as pt hasn't met with rep yet.The patient was redirected to their healthcare provider (hcp) to further address the issue.Patient stated the tech made every effort to service it.Patient stated the weather and covid prevented meeting delay and patient was unable to meet with tech.The tech tried reprogramming it using other lead but had trouble with that, couldn't keep signal off their ribs and had to go back to original leads and try that.Patient stated it's a short in the leads that goes off and on, bad connection on device.

• 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: 11716405
• MDR Text Key: 247009350
• Report Number: 3004209178-2021-06568
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Date Device Manufactured: 03/16/2020
• 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 Age: 70 YR
• Patient Weight: 66