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); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885)

Patient Problems Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: m943899a, serial#: unknown, product type: accessory.Product id: 97745, product type: programmer, patient.Product id: 977a260, serial#: (b)(4), product type: lead.Product id: 977a260, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 19-nov-2023, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 19-nov-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 who was implanted with an implantable neurostimulator (ins).It was reported that the patient mentioned belt product enhancement suggestions.See (b)(4) for longer charging times and controller/ recharger telemetry module (rtm) replacement.It was also reported that the patient had left anterior chest wall stimulation.The patient reported unresponsive screens on the controller and also seeing "system problem rm06" message last saturday.Since then, the patient has been at zero and no therapy delivered.It was reported that the circumstances that led to the chest wall stimulation was due to turning it on after implant at 1st post-op visit.Patient reported lead dislodged stopped chest wall stimulation.Patient stated they got a new donut programmer and battery pack for controller sent.Patient stated the issue resolve due to lead moving on its own.Patient stated they can't get device to fully charge to finish.

Manufacturer Narrative

Continuation of d10: product id m943899a serial# unknown product type accessory.Product id 97745 serial# unknown product type programmer, patient.Product id 977a260 serial# (b)(6) product type lead.Product id 977a260 (b)(6) 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.

Event Description

Patient reported hcp does not think lead(s) moved enough to do anything.Patient reported that rep told them that medtronic pacemaker was causing interference and that during recharge of scs it would only say "finished" when, only if "x" is pressed by patient.

• 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: 12288536
• MDR Text Key: 265419190
• Report Number: 3004209178-2021-12027
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."