MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Data Problem (3196); Patient Device Interaction Problem (4001)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 12/23/2021

Event Type  malfunction  

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).The reason for call was that the ins had been working good except for like two weeks ago.Pt stated that the ins was supposed to affect their left side only.Pt stated that when they turn the device off, the problem was that the stimulation would stay on their right side and it was driving them crazy as it was really hurting down their arm.Pt stated that the stimulation was going up their elbow and everything.Pt stated that when their current ins was implanted, the old leads were left in place.Pt stated that they thought that a lead was either broken or something.Pt stated that they would turn the stimulation on and that the stimulation goes from 1 to 7; pt stated that they lowered the stimulation level and then entered the mri mode to shut the ins off so that they couldn't feel the stimulation anymore; pt stated however that if they moved their neck then the stimulation would go down their right side.Pt stated that this never happened before even with previous implants so they were worried as anything they did was really intense.This was understood to mean that the stimulation was really intense.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13197215
• MDR Text Key: 291281649
• Report Number: 2182207-2022-00039
• Device Sequence Number: 1
• Product Code: LGW
• 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: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2022
• 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: 63 YR
• Patient Sex: Male