MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97725

Device Problems Device Difficult to Program or Calibrate (1496); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c265, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020,product type: lead.Product id: 977c265, serial/lot #: (b)(4), ubd: 25-feb-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 representative regarding a patient with an external neurostimulator (ens).It was reported that the patient¿s trial started on (b)(6) 2020 and has been in pain to the point where they want to vomit.It was stated the patient couldn't get off the couch without help.The patient wanted the ens turned off.The representative was walked though turning the ens off.The patient was trained on the trial under anesthesia and wanted to meet with someone on how to use the controller.The patient was redirected to their healthcare provider to discuss symptoms.Additional information was reported that the patient has been complaining of bilateral rib pain since her trial.The pain is unrelated to stimulator use.The rep believes the pain is related to positioning during the procedure.The patient stated that she started having the pain after waking from surgery.The patient does not wish to have the ins removed because she does like it and feels that is providing her with back relief.However, the physician that performed the procedure wishes to remove the device this afternoon.He feels that it is in the best interest to removed it.There really is no problems with the stimulator, and the patient does like it.The patient was brought to the hospital on (b)(6) 2020 for pain control for her bilateral rib pain.The issue was resolved at the time of the report.No further complications were reported.No additional patient symptoms were reported.

Event Description

Additional information was received from a manufacturer¿s representative (rep).The rep reported that the actual cause of the patient¿s pain was unknown at this time.It was believed that perhaps positioning may have led to this pain but nobody had an answer.The rep reported that the patient was complaining of bilateral front rib pain after awaking from surgery.The wens was discarded.No further complications were reported.

Manufacturer Narrative

Continuation of d11: product id 977c265, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020.Product type lead.Product id 97745fa, serial# unknown, implanted: (b)(6) 2020, explanted: product type programmer, patient.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.

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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 10179093
• MDR Text Key: 200225294
• Report Number: 3007566237-2020-00335
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR