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

Model Number 97715

Device Problems Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

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) for unknown indications for use.The reason for call was last night the pts therapy got super high so pt turned the therapy off and they took the controller battery out of the controller.Pt usually had their settings set on group b at 3.0, 3.2 or at 4.0 sometimes for their leg or back.But last night pt was in a lot of pain and when pt went to turned it on they went to boot it up a little bit and it was super high in stimulation.Pt said the intensity was only at 3 so they put the therapy to a and it was the same for it was blasting them.The pt had to turn it off since it went in the highest mode ever.Pt could turn the programmer down but there was a malfunction for it was not programming like they wanted it to.The patient was redirected to their healthcare provider to further address the issue.Pt had contact information to their medtronic rep and pt will contact them.Pt noted they could go to groups a, b, or c.

Event Description

Additional information was received from the patient.The reason for call was that the patient (pt) had numerous problems with the charger and this time the problem was that the controller was blank and they couldn't turn the device on or off or up or down or anything.Pt stated that the ins was just about dead.Patient services (pss) advised the pt that troubleshooting would possibly resolve the issue; pt interrupted pss and stated that the rep had to work them through things just to keep the device running and that the rep thought that the controller needed to be replaced.Pt stated that a couple times all of a sudden everything was on full at a nine and it was so high that they couldn't get it to go down (pss understood that the pt was referring to the stimulation intensity being at a 9); pt stated that they finally got it down though.Pt stated that they had reset the controller and that a couple times th they went to recharge and the controller said to call mdt with a code (pt couldn't recall code).Pt then stated that the button on the top of the controller had moved down into the controller so they couldn't hardly press the button anymore; pt stated that they could do it with their fingernail but not with their finger.Pss understood that the button on top of the controller was stuck down.Pss had the pt connect the ac power supply to the controller without the battery pack inserted; pt confirmed that the controller powered on.Pss then had the pt reinsert the battery pack into the controller "while the" controller was still connected to the ac power supply; pt confirmed seeing the green light flashing above the screen.When asked for the event date, pt stated that it was about two to three months ago.An email was sent to the repair department to replace the controller.

Manufacturer Narrative

Continuation of d10: product id: 97745, serial# (b)(6), product type: programmer, patient.B3: date is approximate.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: 14301119
• MDR Text Key: 299699572
• Report Number: 3004209178-2022-05725
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2022
• Date Device Manufactured: 07/06/2018
• 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: 69 YR
• Patient Sex: Female