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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Failure to Power Up (1476); Use of Device Problem (1670); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97745 lot# serial# (b)(6) product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 97745, serial/lot #: (b)(6), udi#: (b)(4).This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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).The reason for call was the patient (pt) mentioned the "unit would not take a charge any longer" since 3-4 days ago.Pt clarified that the controller went blank/unresponsive and would not turn on.During the call, the pt reset the controller and the controller responded.Pt saw a green light blinking on the controller when the controller was plugged into the ac power supply and li battery pack was installed.Pt then unlocked their controller and the controller displayed "no device found." pt plugged in the recharger antenna (rtm) and pressed "recharge." pt successfully initiated a charging session of their ins with a recharge quality of "excellent." pt had to undress to charge their implanted neurostimulator(ins).Pt mentioned it took them 30 minutes to charge their ins.Ins charge was low on the call and controller charge was 100%.The troubleshooting steps that were taken on the call resolved the issue.Pt said they had trouble moving.Pt said their implanting hcp was dr.Brian h kopell.On (b)(6) 2022 the pt called back from registered number because their issues weren't resolved.Pt re-reported previously documented information from the call code notes.Pt noted they couldn't power up their controller and their controller wouldn't take a charge.Pt noted their controller screen went white and they saw black and white a "100%" in the upper right hand corner and their controller was blank/unresponsive.Patient service specialist (pss) helped the pt perform a reset of the controller and confirmed the green light was blinking on the controller when plugged into the outlet.Pt unlocked their controller and their controller battery was at 0% and their ins battery was at 60%.Pss reviewed the external equipment was functioning as intended.Pss suggested the pt monitor their device and call back if necessary.On (b)(6) 2022 the pt called back because they still couldn't charge their implanted neurostimulator (ins) since a "few weeks ago" and this was their "third incident." pt noted they were charging their ins for more than an hour and they couldn't increase the ins battery percentage.Pt noted the ins battery would go to empty and not take a charge.Pt confirmed they didn't see any error messages on their controller when charging their ins.Patient service specialist (pss) helped the pt perform a reset of the controller and confirmed the green solid light was on the controller when plugged into the outlet.Pss helped the pt inspect the controller port, the controller battery pins, and the li battery pack contacts, but no visible damage was detected.Pt initiated a charge session to their ins and saw a yellow blinking light at first when charging, but then saw a green blinking light and was charging with excellent quality.Pt mentioned placing the recharger antenna (rtm) over their back was sometimes "tricky." pt noted the controller battery was at 100% and their ins battery had a "red stripe" (pss understood this as their ins was depleted).Pt added they "interrupted" the use of their device when they were in the hospital.Pt confirmed their hospital visit was not related to complications with the spinal cord stimulator (scs).Pss reviewed the external equipment was functioning as intended.Pss suggested the pt continue to charge their ins with excellent recharge quality and call back in 2-3 hours if their ins battery % still didn't increase.Pt noted they had to go somewhere and would try charging their ins later in the day.

• 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: 18569697
• MDR Text Key: 333551741
• Report Number: 3004209178-2024-01902
• 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: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2022
• Date Device Manufactured: 09/16/2020
• 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
• Treatment: "SEE H10...."
• Patient Age: 87 YR
• Patient Sex: Male