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); Malposition of Device (2616)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.Patient doesn't feel their stimulation.Caller said the pt had the stimulation up to 2.20 on all 4 settings and they were finally feeling something in their right leg, however, their ins was in the left side.When they spoke with rep , the rep had them take the battery out of the controller and leave it out for 10 minutes.Pt said that did not resolve their problem.Pt said they did not have any recent falls or trauma and pt confirmed their stimulation was on (pt was on group c).Controller appeared to be functioning as intended.Additional information received.Rep responded from follow up sent.Patient education issue and patient was re educated on how to work remote and increase stimulation.Reprogrammed patient over the phone.Patient is feeling stimulation and is following up with pain management on how he wants to continue, as patient feels he has been re-programmed and still not getting desired pain relief additional information received.Patient is reporting that their incision site has not healed and it's sore.Patient re-iterated that they are not getting therapy relief from the implant.Patient stated it takes 1hr 4min to charge their ins from 40% to 100% at excellent recharging quality.Patient stated rep had them reset the controller and called for controller replacement but the controller did not get replace.Patient reported they think the screws were placed in the wrong place.Patient reported he was getting stimulation on the left leg with the old ins, and now he is getting little stimulation on the right leg when hillary did programming and that was it.Patient stated he met with dr le, physician assistant a month ago and last week and they are aware they incision is not healed.Patient stated he was schedule to get a nerve block but the schedule kept getting changed.Patient services (ps) asked patient to connect controller to implant, controller showed 70%, ins 80% charge.Ps asked patient to inspect the recharger (rtm) for damage or if the rtm gets hot when recharging and patient said there is no damage to rtm, the little box gets warm but not hot.Ps asked patient to start a charging the implant and patient is getting excellent recharging quality.Ps confirmed the controller is charging when plug into the outlet.Ps reviewed the external devices seem to be functioning as designed / normal.There is not reason to replace the external devices.Ps recommend patient consult with his healthcare provider regarding his concerns with therapy and the incision healing.Information regarding wrong placement captured in (b)(4).

Event Description

Additional information received.Rep reported the paddle implanted is not midline in spine and both surgeon and hcp are aware of this issue.Rep has tried to re program the device as well as other reps and not successful.Patient will need to follow-up with hcp and surgeon.During the last visit with hcp, hcp let patient know to return to surgeon and have him check it out and potentially see if the device could be removed since it is not working for him and patient stated ¿he was just going to let it die as he did not want another surgery.¿ issue has not been resolved.Information regarding wrong placement captured in 704193462.

Manufacturer Narrative

Continuation of d10: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2021 product type lead 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: 12287388
• MDR Text Key: 265373215
• Report Number: 3004209178-2021-12013
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR