MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC

Model Number NEU_ENS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abscess (1690); Cerebrospinal Fluid Leakage (1772); Pain (1994)

Event Date 10/13/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a manufacture representative regarding a trial patient with a wireless external neurostimulator (wens).It was reported that the patient started having new pain 5 days in to their trial on (b)(6) 2018.The patient went to the emergency room (er) and found that the trial lead had migrated so the doctor pulled the lead.The patient still had pain so they got an mri which showed that they had an epidural abscess.No further complications were reported.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 the rep reported that the epidural abscess was misdiagnosed and that it was actually a spinal fluid leak.No further complications were reported.

• Brand Name: MEDTRONIC
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7969523
• MDR Text Key: 123838815
• Report Number: 3007566237-2018-03042
• 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
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR