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

Model Number 97715

Device Problems Failure to Charge (1085); Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2020

Event Type  malfunction  

Event Description

Information was received from a patient.It was reported that the donut part of the recharger felt hot and was making a clicking sound.When the patient received the recharger, they reported that they kept getting an ¿unable to charge, try again¿ message, but after resetting the controller and starting passive workflow, they were able to get excellent recharge quality and charge their implantable neurostimulator (ins).It was initially reported that the recharger had not worked well since the patient was implanted, but then the patient clarified on a different date the recharger donut would feel hot and they had been getting a ¿no device found¿ error message.During the call, the patient was getting a ¿poor recharge quality¿ screen, where it then showed excellent and then back to poor quality.The repair department was contacted and a replacement recharger was requested.No patient symptoms were reported.Indication for use is spinal pain.2020-08-18: additional information was received from the patient.The patient reported that their new recharger was not working.Troubleshooting steps were performed during the call.After the patient performed passive recharge mode, they were now able to charge their implantable neurostimulator (ins) with excellent recharge quality.No further complications were reported or anticipated.2020-09-01: additional information was received from the patient.It was reported that their controller was not changing screens when the recharger was plugged in.The patient stated that it worked for a while, but they could not get the controller to charge their implantable neurostimulator (ins).The patient was redirected to the repair department and a replacement controller was requested.No further complications were reported or anticipated.2020-09-02: additional information was received from the patient.It was reported that they received their new controller and needed help setting it up.During the call, the patient saw a ¿no device found¿ screen when connecting the recharger to the controller.The patient was unable to get passive recharge to work, as they went through several cycles, but their implantable neurostimulator (ins) still would not charge.The patient mentioned that they hadn¿t ever really gotten a chance to use the equipment because it still was not working.The patient was redirected to the repair department, where they were successfully able to get passive recharge to work.It was noted that a replacement recharger was requested.No further complications were reported or anticipated.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6) udi#: (b)(6) h3: analysis of the 97755 recharger (rtm) (s/n (b)(6)) revealed no anomaly of the recharger telemetry module (rtm).This regulatory report is being submitted as part of a retrospective review as part of a capa 620188 action.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.

• 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: 17106369
• MDR Text Key: 317132591
• Report Number: 3004209178-2023-10351
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1535-2021
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female