MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7425

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Low Battery (2584); Battery Problem (2885)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported via the manufacturer representative that the implant died about eight months ago.The patient stated the implant had turned on by itself intermittently.No error codes were reported and no falls or traumas reported related to the issue.It was noted that the device had a magnetic reed switch which was enable, but could be disabled.It was reviewed to set amplitude to 0 so if it toggled on the settings would be zero.Troubleshooting resolved the issue with reprogramming the switch off.The indication for use was other chronic/intractable pain of the trunk/limbs.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer¿s representative (rep).The rep reported that the troubleshooting performed related to the device turning on intermittently was that they interrogated the neurostimulator (ins).The rep reported that the cause was not determined.No further complications were reported.

Event Description

Additional information received from a healthcare provider (hcp).It was reported that the patient's stimulator was dead and it was unknown if it was depleted due to normal battery depletion.No further complications reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ITREL 3
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7209887
• MDR Text Key: 97992804
• Report Number: 3007566237-2018-00227
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 01/22/2018; 01/29/2019
• Supplement Dates FDA Received: 02/16/2018; 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR