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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was caller stated that their manufacturer representative (rep) told them to call for a replacement recharger.Caller stated for the last month their implant has been acting up.Caller stated that sometimes the implant doesn't want to charge completely and sometimes it takes an hour and a half to charge.Caller added that the monitor says that stimulation can't be read at this time.Caller mentioned that this is the second time this has happened, and they are going to see rep on monday to look at the monitor again.Caller repeated that rep thinks the recharger needs to be replaced.Agent attempted to ask clarifying information, but caller was vague with their response.Caller did not have the equipment at the time of the call.Caller will be calling back with their external equipment.Patient called back to provide serial numbers to external equipment.During the call, agent walked patient through resetting the controller with the ac power cord.Patient confirmed no damage to the controller port or pins, recharger cord and pins.Agent walked patient through a recharging session and the patient confirmed recharging excellent.During troubleshooting the patient reported "settings not available, cannot provide your desired intensity settings (59)".Patient mentioned the reason they're concerned about their equipment is because they cannot feel stimulation and their implant has not depleted at the rate it normally does.Agent reviewed information with the patient.The issue was not resolved.Agent re-directed patient back to their hcp and mdt rep.Caller reported they are meeting with a rep on monday.

Manufacturer Narrative

Date is approximate.Year is confirmed valid.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: 18826579
• MDR Text Key: 337761702
• Report Number: 3004209178-2024-06181
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2024
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2024
• Initial Date FDA Received: 03/04/2024
• Date Device Manufactured: 07/20/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Male