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

Model Number 97715

Device Problems Failure to Interrogate (1332); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: 97715, serial#: (b)(6), implanted: (b)(6) 2023, product type: implantable neurostimulator.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

2024-jan-11: information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain indications.Caller states pt has two ins's--one for c-spine and one for t-spine.Caller notes they are both located in the flank and per their guess are approx.5 inches apart.The caller notes the ins's are far enough apart where the rtm's do not overlap when pt attempts to charge both ins's simultaneously.The caller states the pt has no issues when using their controllers to connect to the ins's simultaneously; however, when the pt attempts to charge the ins's at the same time they are unable to do so and can only charge one ins at a time.The caller notes that the pt's ins's in this instance were 50% and 60% charged when attempting to charge both.The caller states that for some brief period of time, when each controller screen shows the message to place the recharger telemetry module (rtm) over the ins and press 'continue' to charge they can charge both but thi s charging does not last for both.The caller notes that the pt will have one ins charging and the other controller for the other ins will show 'no device found'--the caller indicated that the pt has been trying to press 'retry' so agent noted thept should be pressing 'recharge' instead.Agent noted that the caller can try to flip-flop between which is charging and which is showing 'no device found' so they can attempt to get both charging and also consider placing a barrier between the two while charging to see if that helps resolve.The caller will continue to work with pt and agent to pursue potential additional guidance from the team.Agent reviewed ifp regarding 'neurostimulator location' and based on the ifp the systems would appear to be far enough apart, agent did reference legacy labeling where the recommendation is 8 inches.2024-feb-22: additional information was received from a manufacturer representative (rep).The rep reported that the ins's are too close together.Unable to charge.Right ins moved more lateral.Patient was doing well.Later, rep called in with patient to discuss recharging issues pt has been having since having the right ins moved to a different location.Per rep ever since then pt claims to have not been able to charge the ins since then and that ins has been off since surgery.Rep states they are right over battery, sees poor recharge quality and then it freezes.For the past 20 mins been seeing same thing, finally got to the passive recharge screen where she can see the antenna numbers and it bounces around from 26-48.Reviewed ins may be depleted and need to complete this passive recharge sessions for 10 min up to 3 x.It was noted that they are able to see that battery is in the red.Reviewed importance of recharger telemetry module (rtm) placement, effects of swelling in the pocket area and effect in recharging.Reviewed to consider disable/enable the device, try pt's other rtm to see if same thing happens.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Rep reported that ipg moved on (b(6) 2022.The issue has resolved.Patient can now charge both simultaneously.Patient's weight was unknown.

• 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: 18961031
• MDR Text Key: 338379651
• Report Number: 3004209178-2024-07665
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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 Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/10/2024
• Date Device Manufactured: 07/05/2023
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female