MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 353101

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

Patient Problems Pain (1994); Urinary Tract Infection (2120)

Event Date 12/09/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a trial patient who was implanted on (b)(6) 2018 for a verify enhanced basic evaluation (be) for non-obstructive urinary retention.It was reported that the trial patient had a terrible pain in their bladder/uterus area.It was advised that they decrease the stimulation but this did not help.When the therapy was turned completely off the pain still remained.It was advised that the patient contact their medical professional/clinician for the issue.It was unknown if there were any environmental/external/patient factors that may have led to the issue.Follow up information received on (b)(6) 2018 reported that the patient still had a uti.There were no further complications reported or anticipated.

Manufacturer Narrative

Review of the additional information received shows that there is now information to reasonably suggest that the device in this report did not cause or contribute to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.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 was received from a health care provider (hcp).The hcp wrote in regards to the first question inquiring the patient's history of utis prior and since implant that the "urine culture no "illegible word" (b)(6) 2018" the hcp reported that incomplete emptying was the cause of the reported uti and that the uti was related to the patient's underlying urinary dysfunction.The hcp reported the uti was not related to the device and/or therapy and the actions/interventions taken were that antibiotics were administered.There were no further complications reported/anticipated.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8205301
• MDR Text Key: 131701005
• Report Number: 3007566237-2018-03736
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

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: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2018
• Initial Date FDA Received: 12/29/2018
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 47