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

Model Number 97715

Device Problems Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023); Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

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 (pt) regarding an implantable neurostimulator (ins).The reason for call was pt said for awhile now (confirmed 2020) the controller had been working against them when trying to change their stimulation.Pt said they weren't getting enough therapy as far as frequency or power so had met with their manufacturing representative (rep) who "opened enough electrodes" to go just enough to 11 (pt said they can only go to 10.6-10.8 as rep said they wouldn't be able to go all the way to 11, patient services (pss) understood this as therapy optimization and not an allegation).Pt said sometimes they need real powerful therapy and will be at the 10.6-10.8 and will see that it sometimes will go back to 9.7.Pt will try to go back to 10.8 but said it will tell them that the intensity is not available and that it is a "labor to get back up".Pt said when they are on the lower ranges (s ometimes needs it lower), it makes it even harder for them to get back up "may take me 3 days to getback up to 10.8".Pt said their body doesn't have time to wait for the controller to adjust and that the controller is working against them.Pt only had group a program 1.Pss reviewed the role of the rep and how different groups/programs may make it easier for the pt to switch stimulation levels (pt said scs was placed for hips, quads and lower legs).The patient was redirected to their healthcare provider (hcp) to further address the issue.

• 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: 11652733
• MDR Text Key: 254014579
• Report Number: 3004209178-2021-05866
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Date Device Manufactured: 01/15/2020
• 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 Age: 64 YR