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); Use of Device Problem (1670); Delayed Charge Time (2586); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 (pt) who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The reason for call was that they couldn't get the ins battery charged.Pt said that they couldn't get the recharger to register with the controller.Pt said that when the ins was charging the controller light blinked green and recharging excellent would be indicated.Pt said that they had been recharging the ins since seven this morning and the ins started out at 20% and the ins was only at 30% now.Pt said that if they moved their hand off of the recharger then the ins would quit charging.Pt said that they didn't have this problem with their last ins so they thought their current ins was implanted too deep.Pss had the pt remove the battery pack from the controller and connect the controller to the ac power supply; 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 controller light flashing green.Pss had the pt unlock the controller; the controller was at 80% with recharging indicated and the ins was at 30%.Pt saw no apparent damage to the recharger.Pss had the initiate an ins recharging session.Pt said that the recharger wouldn't stay on the implant so their wife was holding the recharger over the ins for them.Pt said that they could never find the ins.Pt saw recharging excellent with the controller light flashing green.Pt then saw poor recharge quality; pss reviewed screen meaning with the pt.Pt said that they finally found the ins when they first started using the device and so they had taken a pencil and drew around the paddle when recharging excellent was indicated but since the markings had faded out.Pt said again that recharging excellent would be indicated but if they moved their hand then the ins quit charging.Pss understood that the recharger was not staying in place properly over the ins.Pt saw recharging excellent appear and the equipment stayed on recharging excellent for the rest of the call.Pss redirected to hcp to further address the issue as the equipment was working as intended during the call.Pt said that they had been having this trouble ever since their current ins was implanted.

• 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: 18234218
• MDR Text Key: 330564141
• Report Number: 3004209178-2023-24496
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2023
• Date Device Manufactured: 09/16/2022
• 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
• Treatment: "SEE H10...."
• Patient Age: 81 YR
• Patient Sex: Male