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

Model Number 97725

Device Problem Energy Output Problem (1431)

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Sleep Dysfunction (2517); Fluid Discharge (2686); Insufficient Information (4580)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a trial patient via manufacturer representative who was using an external neurostimulator (ens).It was reported that the patient started their trial last (b)(6), and started to feel new pain on left side in her mid-back as though "someone is punching her in the kidney." the left-sided mid back/side pain comes and goes, but it was as bad as its been sunday night into monday morning.The patient reported they could not sleep sunday night and woke up in pain, had some issues with her legs being weak, and had 2 episodes of urinary incontinence.The patient reported that this was something that had not occurred since she had been on the trial.It was reported that the manufacturer representative(rep) tried adjusting programming and turned down the intensity.It was reported that when the stimulator was at a lower intensity, the patient felt better.The patient had come into the clinic in a wheelchair because she said her legs were locked up and "not working right" and after being reprogrammed, the patient left walking out of the clinic under her own power.The rep and the patient discussed pulling the leads at that time or finishing the trial and the patient elected to go home and finish the trial.  a healthcare provider noticed some drainage and bleeding on the patients bandage but determined everything was alright.The patient reported they had been getting good therapy relief for her pain during the trial, but the new pain had gotten worse and the patient went to the er on march 29.The patient reported that this new pain got worse or better when stimulation was increased or decreased, respectively so the new pain seemed to be related to stimulation.  it was later reported that the products were explanted march 30; it was determined that the patient was dealing with a possible infection and was admitted to the hospital.

Manufacturer Narrative

Continuation of d10: product id: 977d260, serial# unknown, implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: screening device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The causes of the pain, hospitalization; potential infection were not determined.Hospital administered iv antibiotics and monitored.The issues were resolved.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11596850
• MDR Text Key: 243198802
• Report Number: 2182207-2021-00558
• 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
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention