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); Migration or Expulsion of Device (1395); Unstable (1667); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient stated that it was difficult to get the recharger/controller to stay connected to the ins for charging and it was taking a long time to charge.The patient did not have the recharger at the appointment so troubleshooting was not conducted.The issue was not resolved through troubleshooting.The caller will have the patient follow-up with patient services when they have access to the recharger.Additional information was received from the patient.The patient called back stating they're still experiencing issues while attempting to charge their implant.The patient stated it won't connect to charge.A replacement recharger was sent to the patient.No symptoms were reported.Additional information was received.The patient (pt) called back from registered phone number for assistance charging, pt received new recharger (rtm).The controller was showing 'no device found" when pt attempted to connect wirelessly.The pt was walked through connecting the rtm and the pt saw 'no device found, retry/recharger", when pt clicked recharge, the implant started recharging at excellent, implant battery was low.During call pt was seeing excellent recharge quality but then saw poor recharge quality and had to reposition the rtm a couple times to achieve coupling.Pt said this was probably because of the position their implant battery was in because the implant got pushed back a little far (pt said implant moved a couple months ago).Pt said that their healthcare provider (hcp) thinks that sutures holding the implant down came undone and the implant was floating around in too big implant pocket.Pt said hcp plans on revising the pocket but didn't know the date yet as the pt was waiting on insurance to approve.

Event Description

The rep reported that the patient had another implant surgery on (b)(6) 2021.At that time, the doctor moved the first battery to a more convenient location for charging.Patient has not had any complaints since that time.The issue has been resolved at this time.

Manufacturer Narrative

Continuation of d10: product id: 97755, serial# (b)(6), 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.

• 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
• MDR Report Key: 12297712
• MDR Text Key: 265830922
• Report Number: 3004209178-2021-12111
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR