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

Model Number 97715

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that since implant, the patient was experiencing pain off and on in their leg; the therapy was intermittent.The pain was so bad that it was keeping them up at night.The patient confirmed this was the pain they got the device for.They did try increasing stimulation, but that did not help.On (b)(6) 2020, they had tried increasing stimulation but couldn't feel it until it got to 7.5 ma.Additionally, the patient had been having trouble getting the ins to charge.They explained that they were getting the poor recharge quality screen.They tried laying on their stomach and holding the recharger therapy module (rtm) in place, but they still got the poor recharge quality screen.It was confirmed that the patient no longer had bandages on their implant site.During the call, they tried connecting to the ins, but they got the poor recharge quality screen again.They eventually got excellent recharge quality, but then it switched back to poor recharge quality.The patient reported they would have to work at connecting the controller to the ins for 30-45 minutes before it would connect, which was frustrating for the patient.A replacement rtm was sent to the patient.No symptoms were reported.Additional information was received from the patient on july 31, 2020.The patient provided clarification regarding "therapy was intermittent".They explained that they meant the stimulation was going up and down.The device was very hard to charge even after getting a replacement rtm, and it did not resolve the inability to connect to the ins to charge it.They confirmed that the adaptive stim (as) feature was on/active at the time of the intermittent therapy; they had never turned as off.The cause of intermittent therapy and the recharging difficulty was because the ins was laying down, so they had to have a surgery to fix it; they were now able to charge the ins.

Manufacturer Narrative

Continuation of d11: 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.

Event Description

Additional information was received.It was reported the patient had their device replaced in (b)(6) 2020.In which it was not sitting in their body correctly and had to be re-installed in (b)(6) 2020.The patient stated it did charge correctly now, however they were not happy that the device needed to be charged every night.They had also experienced more pain with their current device then their older one.The older device had kept a charge for a month.The patient's new device would shut off if they forgot to recharge it.It was noted it was inconvenient to have to deal with that every day.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10376232
• MDR Text Key: 201945635
• Report Number: 3004209178-2020-13604
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 74