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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 04/17/2021

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 (pt) who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The reason for call was pt said they had been in a lot of pain for the last week or so (confirmed they first noticed it 3-4 days ago).Pt does not think their device is working, thinks the device will come on in the evening for an hour or so.Pt mentioned with certain movements or coughs, they can feel it (pt said they had not had any falls or trauma).Pt saw recharge the implanted device soon screen but said even after they recharge the implant, they still were unable to feel stimulation.Pss had pt turn stimulation on, but pt was advised not to change any stimulation settings by their rep.Pt thinks they have adaptive stimulation but said they think they are still working on that.Pss reviewed to recharge their implant and then pss redirected the patient to their healthcare provider to further address the issue.Redirected caller: patient's hcp.

• 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: 11710524
• MDR Text Key: 267329504
• Report Number: 3004209178-2021-06523
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Date Device Manufactured: 02/16/2021
• 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: 53 YR