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

Model Number 97715

Device Problems Unstable (1667); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Pain (1994); Sleep Dysfunction (2517); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for spinal pain.The patient reported that they were having ongoing issues with their device since around (b)(6) 2021.They explained the ins would not charge even after doing a hard reset on the controller.After doing a reset, the rm04 error message would continue to occur intermittently, and seemed to be getting worse gradually.The controller would indicate that recharging was excellent, but the ins charge would not progress, but rather deplete to 30% instead of progressing when the patient had been charging for over two hours.They had woken up in pain because the ins was low/depleted.The patient confirmed they always started a charge when the controller was charged to 100%.They also confirmed that they were using adaptivestim settings.It was reviewed how different settings can affect battery depletion and recharging needs.The patient confirmed they didn't see any physical damage to the equipment, and the recharger wasn't getting hot while charging.They did note that they twist the recharger cord to fit the cord into the belt, but they were trying to k eep the cord as straight as possible.Additionally, they were seeing a message like "poor recharge quality" while charging, and the patient would resolve this issue by unplugging and plugging the recharger back into the controller.The issue was not resolved on the call, so an email was sent to the repair department to replace the recharger.Additional information was received.It was reported it usually did charge up to 100%.In the past 2 weeks, 4 times after indicating excellent charge status, the unit did not charge until they reset it by removing the battery for a minute.On (b)(6) 9:30-9:32 am the ins was charging excellent then a tone sounded and unit displayed interrupted, they unplugged and replugged the cord.The patient began excellent charging again.Another tone sounded and displayed rm04.The patient took out the battery for a minute and the recharger began charging again.It was noted the circumstances that led to the recharging issues was the patient strained their body accidentally but not in an accident on occasion but the unit had been doing it before that.The patient had an appointment scheduled with their healthcare provider for (b)(6) 2021.Additional information was received from a manufacturer representative (rep) and a patient (pt).It was reported that rm04 was seen on the controller according to a message.The rep will contact the patient tomorrow (2021-10-06) to troubleshoot.The pt called and reported that yesterday (b)(6) 2021 she met with the rep at the healthcare provider's (hcp) office.The pt had seen the hcp on (b)(6) 2021.The hcp asked the rep to check the ins due to recharging difficulties.The pt stated she has had issues getting the ins to recha rge in the past 4-5 months.The rep reviewed screens that the pt had sent him previously.The pt stated that the rep indicated that she needs a new recharger (rtm) cord.The pt stated she has lost some weight since implant in (b)(6) 2019 and the pt can easily feel the edge of the ins and the ins is at an angle in the pocket.The pt stated that the hcp feels the ins should have been implanted closer to the spine.The pt stated that the rep feels the angle of the ins could be causing some of the charging issues; the rep suggested that the ins does need to be moved based on the ins position.A replacement rtm cord was sent out.

Event Description

It was reported that there was a plan to remove the battery.Unrelated to charging.The patient required recharging education.The rep reported that the recharging issues arise when patient would let internal battery deplete.Starting seeing the over discharge screen with the ¿wait 10 minutes¿ instructions and it caused concerns.The rep reported that issue is with discomfort caused with the current battery placement (its on her side on top of hip) will be moving it to lower back/flank.The rep reported the recharge issues doesn¿t appear to be from battery placement as they were able to easily locate with the antenna and receive ¿excellent¿ connection.The rep reported that date to move the ins remain unknown.

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger 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.

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# (b)(6),product type recharger product id 97755 lot# serial# (b)(6), product type recharger h3.Analysis was performed on [product id 97755 lot# serial# (b)(6) analysis found that there was a recharge antenna failure, controller wont power on when rtm is plugged in.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411 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.

• 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: 12601626
• MDR Text Key: 279583439
• Report Number: 3004209178-2021-15110
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• 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: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 71 YR
• Patient Sex: Female