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); Failure to Interrogate (1332); Delayed Charge Time (2586); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fbss upper limb/neck and spinal pain indications.The reason for call was pt was having another surgery on (b)(6) and the pt was asked to make contact with medtronic to be showed how to turn their scs and urinary stim device off.Pt noted they had both their controller and stimulator charged fully on saturday but now when they turn it on the controller had no charge.Pt found out there was an electrical problem where they stayed at and the pt knew they needed to have their medtronic device fully charged to change the settings but the controller was not charged because if they pushed a button it would not turn on.Pt noted when they put the rtm ring on it would not do anything (pt verified because the controller was not charged).Ps reviewed with pt how to turn their stimulation off.Pt noted they had to go into mri mode a few weeks ago for an mri.Additional information was received from the patient.Pt called back stating they had the procedure/surgery on (b)(6) and had to have an mri.They went into mri mode and turned both scs and ph devices back on after the surgery.Pt charged device since then but they were not keeping charges.Pt also did not feel stimulation.Pt said they were still in a hospital and mentioned they had problems with anesthesia, pt cannot get it together.Pt was confused which device was not working: the bladder one or scs.Pt then said the scs one was not charging.Pt said yesterday the ins was at 100% and today only at 60%.Pt used the device on the call and got no device found.Pt pressed recharge and was charging with excellent recharge quality.Pt said both batteries were at 100% at 2am.Now the ins was at 50%.Pt said they did not change settings.Later on the call the charge went up to 70%.Pt will keep charging.Had pt also confirm that stim was turned on.Since pt was not feeling stim, instructed pt to increase.Pt increased stim in group a and confirmed they could feel it a little and will stay at that level.Pt mentioned this ins takes longer to charge compared to the other ins.Reviewed rate of depletion depends on usage and settings.Pt mentioned they met with a rep a few weeks ago.Pt also mentioned their batteries were deeply implanted.

Manufacturer Narrative

Continuation of d10: product id 97745 lot# serial# unknown implanted: explanted: product type programmer, patient 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: 18951348
• MDR Text Key: 339047034
• Report Number: 3004209178-2024-07523
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2022
• Date Device Manufactured: 11/08/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Female