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

Model Number 97715

Device Problems Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Burning Sensation (2146); Discomfort (2330)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient was taking two hours to charge and if she moved even an inch, she lost communication.Charging taking too long and poor communication were noted.The patient did not have issues with their previous antenna/recharger charging this device.The implant site also was painful and heated up.The patient advised that the implant was protruding a bit from the implant site and there was a nerve there according to her healthcare professional (hcp) that could be causing the heat and pain.The patient was asked to secure the recharger in place and the patient suggested her husband's belt or shirt which did not work.They already lowered the intensity on the programmer to reduce the heat.The antenna was replaced, and the patient was advised to follow up with her hcp if this didn't work.The issue was not resolved as of (b)(6) 2020.No surgical intervention occurred or was planned.The patient was alive with no injury.The issue occurred during normal use.

Manufacturer Narrative

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 from a healthcare professional (hcp) as part of a clinical study.It was reported that when the device charges very quickly, it warmed up to the point where the patient was uncomfortable.It was noted that the issues were detected at follow-up.The device diagnosis was discomfort due to heat from the device when charging, and the clinical diagnosis was not applicable.Device settings were adjusted to reduce the speed of the charge thus reducing the amount of heat coming from the device on (b)(6) 2020.The etiology was noted to be related to the device or therapy, specifically to the neurostimulator recharge process and heat from the fast charging causing discomfort.Etiology was not related to the implant procedure.It was noted that the patient's age at consent was 70 years old.

• 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: 10298878
• MDR Text Key: 199686057
• Report Number: 3004209178-2020-12477
• Device Sequence Number: 1
• Product Code: LGW
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 72