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

Model Number 97715

Device Problems Overheating of Device (1437); Delayed Charge Time (2586)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

Information was received from a manufacturer's representative (rep) regarding their external devices.The reason for call was rep stated the patient (pt) told them the recharger (rtm) had been getting hot while recharging.Pt used the same rtm for both implants (ins).It was also reported that the controller was not charging the ins as well.Pt spoke spanish but rep asked pt and pt clarified it took proportionately longer to charge the lumbar ins starting 2 weeks ago.Pt said they use the same recharger (rtm) for both cervical and lumbar ins, but only the lumbar ins charge duration was now longer.Rep inspected battery compartment and controller port, but didn't see any damage.The issue was not resolved.An email was sent to the repair department to replace the controller and rtm.Additional information was received.It was reported the patient had two scs, cervical and lumbar implant.Caller reports both are giving patient good coverage.Caller reports patient received her replacement recharger and continues to feel hot and pain only when charging with the replacement recharger.Caller reports the lumbar implant when patient charges, she feels hot and pain at the ins pocket site, only when she is charging.Caller reports she keeps her stimulation on when charging.It was noted the ins was well healed with no redness.A palpation was performed, when stimulation was on the patient felt same type of pain but no heat.When stimulation was off the patient did not feel any pain or heat.It was suggested the patient change charging speed down to 3 from 4.It was suggested to turn off stimulation when charging.It was also suggested to wear thin clothing in between the recharger and skin.

Manufacturer Narrative

Continuation of d10: product id 97755 serial# (b)(6) product type recharger product id 97745 serial# (b)(6) product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6), udi#: (b)(4) h3: analysis of the recharger (product id 97755 serial# (b)(6)) found no anomalies and the rtm never got hot after running it for 10 mins.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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.

• 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: 18951766
• MDR Text Key: 339321055
• Report Number: 3004209178-2024-07537
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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
• Treatment: "SEE H11...."
• Patient Age: 51 YR
• Patient Sex: Female