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

Model Number 97715

Device Problems Break (1069); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616); Impedance Problem (2950)

Patient Problems Undesired Nerve Stimulation (1980); Seroma (2069); Burning Sensation (2146); Discomfort (2330); Electric Shock (2554)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received by a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that there was a burning sensation at the ins pocket site with stimulation on and off, but not while recharging.The patient was thin, all impedances were within normal limits, and no falls or trauma were noted.Stimulation was turned off for 12 hours and the burning was there all the time.The implant was superficial and the header block is at 12 o'clock.When stim is off and the header block is palpated, the patient felt more of a burning sensation.The sensation was also felt on the left side of the ins.It was noted the ins was pressing on a nerve.There was fluid collected around the ins.The burning sensation started first, followed by the fluid collection.The fluid collection was subsiding, but the burning sensation was getting worse.No further complications 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 manufacturer representative (rep) reporting that the cause of the burning sensation was due to the device possibly being on a nerve or fluid in terminal from seroma.It was reported that the patient turned stimulation off completely for a week or so with no improvements with the burning sensation.The issue had not been resolved and the rep was informed yesterday that it had gotten worse and they were requesting a revision.The patient¿s weight at the time of the event was unknown.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep).The rep reported that the device was explanted, and they were going to send it back.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis of the implantable neurostimulator determined that the device passed functional testing, and no significant anomaly was identified.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 the rep.Sensation with stim on/off described as a bee sting, shocking and jolting.Patient also had a seroma in 2 locations at lead incision site and ins pocket site.Caller indicted impedances were normal on (b)(6) 2020.The device was replaced on (b)(6) as the doctor believed the ins was defective.When opening up pocket they observed a fractured lead, caller indicated he did not perform an impedance test prior to case, but using fractured lead had some open circuits.They replaced the lead as well as ins during the revision on may 8th.The devices were going to be returned.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b(6) 2020 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 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: 9853148
• MDR Text Key: 184081154
• Report Number: 3004209178-2020-05676
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/17/2020

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: 01/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/07/2020; 05/11/2020; 05/13/2020; 07/15/2020
• Supplement Dates FDA Received: 04/21/2020; 05/13/2020; 05/14/2020; 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR