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

Model Number 97715

Device Problem Electromagnetic Interference (1194)

Patient Problems Sleep Dysfunction (2517); Ambulation Difficulties (2544); Paresthesia (4421); Increased Sensitivity (4538); Insufficient Information (4580)

Event Date 11/30/2020

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) for unknown indications for use.It was reported that an issue occurred when the pt had an mri 2-3 weeks ago.Pt noted the reason for the mri was due to problems w/ his right knee and that only part of his body was in the mri machine.Pt reports that about 6 minutes into the mri, the pt experienced pulling and tingling around his ins site that required him to stop the mri early.Pt states his body was really sensitive after the mri, he had a hard time walking, couldn't sleep on the side of the ins, and felt "water rippling down his back constantly".Pt states these issues lasted for 18h before he started to feel better.Pt states he charged and turned his ins back on after these issues subsided.Reviewed mri guidelines with the pt.Pt confirmed that the ins was in mri-mode (he has full-body eligibility), and that the mri staff had a week to get the mri guidelines.Reviewed considerations with getting the ins checked.Pt requested a  manufacturing representative (rep) be notified to possibly schedule an appt.At the health care provider's (hcp) office.Pt noted seeing a rep in the past for reprogramming.The issue was not resolved through troubleshooting.

• 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: 11057578
• MDR Text Key: 223637210
• Report Number: 3004209178-2020-22450
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Date Device Manufactured: 03/22/2018
• 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: 46 YR