MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_ENS_STIMULATOR

Device Problems Device Difficult to Program or Calibrate (1496); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3889-28, lot# 0219403907, product type lead; product id 355018, lot# vn 4813067, product type accessory.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 21-nov-2023, udi#: (b)(4), country: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the lead did not respond during intraoperative testing and that the voltage could not be set.The lead was removed as a result of the issue.A new lead and delivery sheath were then used to complete replacement on (b)(6) 2020; this measure was reported as effective.It was noted the patient remained in the hospital for observation at the time of report.There were no further complications reported or anticipated.

Manufacturer Narrative

Continuation of d11: product id 3889-28 lot# 0219403907 serial# implanted: explanted: product type lead product id 355018 lot# vn 4813067 serial# implanted: explanted: product type accessory h6: please note that method code 4114 has been replaced with method code 4117 at this time.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 reported the lead would not be returned because it was ¿implanted and remained in the patient.¿ the lead was not replaced and instead remained implanted as of (b)(6) 2020.There remained no further complications reported or anticipated.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10178517
• MDR Text Key: 195971619
• Report Number: 2182207-2020-00389
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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?: Yes
• 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: 06/19/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention