MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. NEXFRAME BILATERAL; INSTRUMENT, STEREOTAXIC

Model Number DB-2040

Device Problem Insufficient Information (3190)

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

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the socket assembly was attached to the nexframe base and the socket assembly would not move freely.It felt as it something was too tight to allow movement.No environmental/external/patient factors were thought to have led or contributed to the issue.The thumbscrews were looser but they still continued to have the same issue.It was reported they opened up a new kit and the new socket assembly worked well.The issue was resolved at the time of the report.No surgical information occurred or was planned.The patient was alive without injury at the time of the report and no complications were reported or anticipated.

Manufacturer Narrative

(b)(4) no longer apply.Analysis of the nexframe revealed the upper piece of the socket assembly was malformed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.(b)(4) no longer apply.(b)(4) now apply.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion code updated from 11 to 67 due to completion of investigation activities.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.

• Brand Name: NEXFRAME BILATERAL
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 7909911
• MDR Text Key: 122012118
• Report Number: 3012165443-2018-00010
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169214811
• UDI-Public: 00643169214811
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2019
• Device Model Number: DB-2040
• Device Catalogue Number: DB-2040
• Device Lot Number: 082501118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 10/02/2018; 12/06/2018; 01/11/2019
• Supplement Dates FDA Received: 10/09/2018; 12/10/2018; 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 102