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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Product id: 977a260, serial#:(b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 23-dec-2024, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 23-dec-2024, udi#: (b)(4).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) for spinal pain.It was reported that the patient has fallen two times in the last couple of months.The patient claimed that this was due to pain.An x-ray was taken and it demonstrated that his leads have moved, but his cephalad lead is still in a perfect position to obtain primary group a dtm10.The patient has great back pain relief, but his leg pain is back to where he was before the trial.¿ the patient was reprogramming to 33% cycling to extend recharging intervals.The physician is sending the patient for an mri.Surgical intervention has not been planned or performed.The health care professional has no further information regarding this event at this time.

Event Description

Additional information received: rep reported, they took patient off cycling.Which patient says, its improved.He states, his leg pain is actually better than it was from the trial, but still not completely gone.And his back pain is greatly reduced.Also, he has had no more falls.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(6), implanted: (b)(6) 2021, product type: lead, product id: 977a260, serial#: (b)(6), implanted: (b)(6) 2021, 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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12189744
• MDR Text Key: 262244266
• Report Number: 3004209178-2021-11067
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10"
• Patient Age: 50 YR
• Patient Weight: 120