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

Model Number 97715

Device Problems Energy Output Problem (1431); Patient Device Interaction Problem (4001)

Patient Problems Device Overstimulation of Tissue (1991); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  Injury  

Event Description

On 2022-mar-01, information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indi cations for use.It was reported that since about one-two weeks ago, they started noticing when they lay down, the therapy would "go nuts" and would be too strong; pt said the therapy would be fine when walking and upright and mobile, but would be too strong when lying down and the pt would have to turn their therapy off at night when going to bed.Now, the pt noticed they were not feeling their therapy at all even though their therapy settings were higher than normal at 4.0 since yesterday (pt's intensity was typically set in the "high 3's).Pt mentioned their ins was charged at 100% and their controller was charged at 50% (down from 100% yesterday).During the call, the pt had group a and programs 1 and 2 on their controller.Pt was at an intensity 4.0 on all programs.Pt adjusted all programs up to 5.0 and pt said they started feeling their therapy.Pt said they "felt a bit of their therapy" in one leg.Pt confirmed their therapy was turned on.The patient was redirected to their healthcare provider to further address the issue.On 2022-04-22, additional information was received from the patient reporting that their battery was removed and replaced.

Manufacturer Narrative

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

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14312537
• MDR Text Key: 291377107
• Report Number: 3004209178-2022-05779
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: 05/05/2022

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 Expiration Date: 05/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/06/2022
• Date Device Manufactured: 05/21/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 83 YR