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

Model Number 97716

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 12/12/2020

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 patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The reason for call was pt reported after ins was put in, the stimulation was doing good, but pt said then about 4 days ago (later clarified saturday night) all the pain completely came back.Pt's legs started hurting again, she couldn't hardly walk, and pt's back hurt like it did before ins was put in.Patient services asked, pt did try to increase stim intensity on group b up a little already, but didn't know how much to increase.Pt was on group b 3.8 during the call and said was still not helping at this level.Pt then switched to group c and said she felt stim going down both of her legs on 6.2.Patient services asked if this helped with the pain, and pt said she wasn't sure yet because pt was sitting down.Pt mentioned the pain is fine sitting, it is when pt is standing or moving the pain is there.The issue was not resolved through troubleshooting.Patient services reviewed pt can continue to try groups a, b, and c and increasing stim to what is comfortable to try and help with the pain.The patient was redirected to their hcp.The patient reported that the ins slipped 6 weeks post-op.No event lead to the issue.They stated that as a result, the ins was replaced on (b)(6) 2021.

• 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: 11700677
• MDR Text Key: 246481417
• Report Number: 3004209178-2021-06405
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: 00643169781740
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Date Device Manufactured: 08/25/2020
• 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: 71 YR