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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Insufficient Information (3190); Data Problem (3196)

Patient Problems Irritation (1941); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 22-may-2023, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 19-jun-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient and manufacturing representative (rep) regarding the patient's implantable neurostimulator (ins).Information was reported that the patient called saying that she needed to meet up to be reprogrammed.The patient said that the lead was pulling and causing some irritation.It was noted that the patient had a lump on the opposite side of her body from the battery.The rep is not sure what's going on there, but she's going to the er tonight to have it evaluated.Apparently she's having a lot of pain in that area.It's unknown of any factors that may have led to these issues.The rep met with the patient and the patient said her leads are pulling.The patient was also accessed by their doctor for bruising that is occurring on the opposite side of where the battery was implanted.The patient is also complaining that her ins seems to be setting the amplitude back to zero for no reason.The rep noticed that adaptive stimulation (as) was turned off, so they aren't sure if that had something to do with it.The rep also re-oriented and reset the ins.The bruising that the patient had on the opposite side seems to be resolving and the doctor said that the leads looked good so he is not sure why the patient is feeling the pulling.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep on february 12, 2020.They reported they had discussed / confirmed the following information with the physician.It was reported that the cause of the intensity changing to zero unexpectedly was still unknown.The only thing they considered as a possible reason was to reprogram the orientation and adjust the sensor to see if that would help.The cause of what the patient described as the lead pulling was also not determined.The patient did see their doctor who did not see anything concerning with the lead.As far as the rep was aware, the reported issues were resolved.No further complications were reported or anticipated.

Event Description

Additional information was received from the rep.It was reported that the stimulation is turning on and off, on its own.Caller has asked if patient has observed therapy turning off on but it appears that patient has not checked.Rep confirmed that patient has adaptivestim as he has oriented and programmed the patient himself.On 3/6, the rep met with patient at hcp's office and stated that patient continues to say that the system is turning on and off by itself.Rep not exactly sure what¿s happening but was certain that it¿s not the battery shutting off.Rep had the patient go in different positions to show her that adaptive stim is working and changing the amplitude.Rep believed this is a perception thing.Regardless, the rep reset orientation and readjusted sensor.Rep told the patient to read the battery when she thinks it is turned off to see if it actually is but i doesn't think patient is doing that.Rep showed patient how to shut off adaptive stim to see if that makes things less complicated.Patient is also exhibiting more leg pain and the pns system will not address that.Rep told patient if this problem continues she will need to set up an appointment with the hcp.No further complications were reported.

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.

• 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: 9699253
• MDR Text Key: 178786257
• Report Number: 3004209178-2020-03126
• 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,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1