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

Model Number NEU_ENS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Pleural Effusion (2010); Sepsis (2067); Test Result (2695)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977d260, serial (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: screening device.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturing representative (rep) regarding a patient with an external neurostimulator (ens).It was reported that the patient complained of pain.The patient was trailed with a lead on (b)(6) 2017.The trial leads were removed after successful trail on (b)(6) 2017.Upon time of removal, no concern for any device related issues.The patient received benefit from the therapy.The rep was contacted by the patient's wife on 10-04-2017 who stated that the patient was experiencing left shoulder pain and upper back pain.The rep was asked if this was related to the patient's trial.The rep informed the family to contact the patient's managing physician to discuss his symptoms and any questions he might have regarding his trail.The patient's family was agreeable to this plan.The complaint was after the patient's trial lead was removed.No further patient symptoms or complications were reported in this event.Additional information was received from the health care professional (hcp) via the rep.It was reported that the patient developed multiple symptoms several days after the completion of this trial, including joint pain, pleural effusion, epidural abscess, sepsis, and had significantly increased hemoglobin a-1 c.Patient was seen by neurosurgeon and cardiothoracic surgeon for these issues.The patient is discharged home per health care professional (hcp).No further patient symptoms or complications were reported in this event.

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.

Event Description

Additional information received from a healthcare provider (hcp).It was reported that the patient had an infection due to placement.No further complications were reported.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• 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: 7010159
• MDR Text Key: 91352796
• Report Number: 3007566237-2017-04729
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR