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); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 04/11/2024

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the ins was not charged for over two weeks.The rep tried to charge the ins for about two hours using the type of ¿physician recharge mode¿, but this did not work.The antenna locate (al) function showed a number of 96.It was already tried to disable-enable the ins via the technician mode and tried different recharge antenna¿s and controllers, without success.Based on palpation, the ins seemed to be superficial and parallel to the skin.Additional information was received reporting the diagnostics/troubleshooting performed.Patient could not restart ins after completely depletion of ins.Device is not being found, and when trying to charge ins, only metal detection screen was seen.Following actions were taken: change recharger; change internal battery of patient controller; 3) changed patient controller; 4) go to tech modus in patient controller option 4 - deactivate device and afterwards activate device to activate telemetry of ins.None of the actions resolved the issue.The cause of the event was asked.The ins was recently depleted once again completely, and patient could not start the ins charging session (stayed on metal detection screen).This event will be discussed with the physician to see what the next steps will be.The event was not resolved.

Manufacturer Narrative

G2: belgium 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.

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received.An rx was taken but no issues were seen at first sight.The physician is aware of this and will contact the patient to have a follow-up.However, no date was confirmed yet.

• 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: 19185640
• MDR Text Key: 341390325
• Report Number: 3004209178-2024-09792
• Device Sequence Number: 1
• Product Code: LGW
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2024
• Date Device Manufactured: 05/24/2021
• 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