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

Model Number 97715

Device Problems Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Incontinence (1928); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 10/21/2018

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 consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the settings seemed a little erratic.The patient said the settings were change on (b)(6) 2018 because he was in so much pain that he could hardly get out of bed without feeling like he was going to piss himself.The rep changed the settings and it felt pretty good for a while, but now the patient was having issues.The patient said he is set at 4, but sometimes it feels like it is at a 5 or 6.It was confirmed that stimulation feels like it is too high.The patient said that happens if he is standing or if he is seated and puts his feet down.Then, it will be painful and bother his right leg.The patient also thinks he is having issues at night because he tosses and turns a lot and his bed looks crazy in the morning.The patient said he has tried decreasing stimulation, but then it will go back up again.It was confirmed that the patient uses adaptive stimulation.The patient was told by the manufacturer representative (rep) to try the settings a couple of weeks, but the patient didn't think they could wait that long.The patient said he was on group c.The patient sat down with his feet down and was at 3.8v.He kicked it up to 4.4v and it was too much, so he decreased to 4.2v where he said it felt pretty good.It was reviewed to keep it set there and if he has any other issues to follow up with the hcp.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer regarding the patient.It was reported that the cause of the erratic stimulation and the stimulation being too high was not determined.The patient had an appointment on (b)(6) 2018 with their clinic.The erratic stimulation and stimulation being too high has been resolved.There were no further complications reported or anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8009051
• MDR Text Key: 125196639
• Report Number: 3004209178-2018-23992
• 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,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2018
• Date Device Manufactured: 07/24/2018
• 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: 75 YR
• Patient Weight: 93