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

Model Number 97715

Device Problems Electromagnetic Interference (1194); Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Burning Sensation (2146)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745, serial#: unknown, product type: programmer, patient.Product id: 97755, serial#: (b)(4), product type: recharger.Product id: 97745ac, serial# unknown, product type: accessory.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a manufacturer representative regarding their implantable neurostimulator (ins).It was reported that it was taking the patient a lot longer to charge the implant and the implant was getting super-hot when they charged.The stated that it felt like the implant was burning.They mentioned their external equipment would get warm, however the implant was the device getting hot when recharging.They had an mri, 3 months prior, and that is when the issues started.When they first got the implant they could charge in 1.5 hours, but now they would start at 40% and would have to stop charging because the controller battery would deplete before they completed charging their implant.It was further reported that the manufacturer representative met with the patient on (b)(6) 2020 for additional troubleshooting assistance.It was unknown if the issue was resolved or if surgical intervention was planned.The patient was keeping the screen active during the charging session, so patient education was provided.The patient had been having trouble charging.The resolution to the issues remained unknown.The patient was informed to try shorter and more frequent charging sessions.Additional information was received by a manufacture representative (rep) and the patient.It was reported the patient had seen the controller be unresponsive to button presses and they resolved it by taking the battery pack out and resetting the controller.It occurred with the rep present and was resolved with a reset.It occurred when the patient was charging the ins.They used the stop button to stop charging then disconnected the recharger from the controller and the screen went dark and unresponsive.It occurred four times in a couple of months.The patient's recharging wasn't working well which started on (b)(6) 2020.The patient was recharging longer than they used to and there was heat associated with charging.The caller indicated that the tablet showed the average coupling was excellent.The average recharge time displayed on the tablet was 1 hour, but the patient claimed it took over 2 hours to charge from 50-100%.The caller stated that the recharging cable looked like it wasn't quite right.The recharging sessions ranged from 2 minutes - 2.6 hours with fair to excellent coupling.At the time of the call they were able to start a recharging session with excellent status.The controller was at 90% and the ins was at 70%.They were charging with a rate of 3 and the caller changed the rate to 4.They indicated the patient kept the recharger screen active for most of the recharging session.They also noted their recharging habits had remained the same the entire time they had been implanted and it used to charge faster.The caller noted they had made programming adjustments over time; like increasing the rate.The rep would have the patient continue charging without the screen active and with the rate set to 4 and re-evaluate later.

Manufacturer Narrative

Continuation of d11: product id 97745, serial# unknown, product type: programmer, patient; product id 97755, serial# (b)(6), product type: recharger; product id 97745ac, serial# unknown, product type: accessory.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 that recharging after last teaching session had gone much better.Issues were resolved and charging was at 3-4 day intervals which was expected.

• 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: 10556801
• MDR Text Key: 208952771
• Report Number: 3004209178-2020-16297
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 95