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

Model Number 353101

Device Problems Failure to Deliver Energy (1211); Therapeutic or Diagnostic Output Failure (3023); Data Problem (3196)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/09/2018

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3057, serial/lot #: unknown, implanted: (b)(6) 2018, product type: screening device.(b)(4).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 fecal incontinence.It was reported that the tape on the trial patient¿s back was itching and they inquired if this was normal.Additional information received from the patient on (b)(6) 2018 reported that they were currently at the maximum level and the stimulation kept lowering when they tried to increase it.The patient was switched over to the opposite side and the stimulation was increased but they did not feel the stimulation.They had reached the maximum level on this side as well.Further information received on (b)(6) 2018 from the patient reported that wires had moved (¿or were off¿).It was unknown if there were any environmental/external/patient factors that may have led to the issue.It was advised that the patient contact their clinician for the issue.It was unknown if the issue was resolved at the time of report.No surgical intervention had occurred and none were planned.The patient status was noted as ¿alive ¿ no injury¿.There were no further complications reported or anticipated.

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

Follow up information received from the healthcare professional (hcp) reported that the cause of the trial patient not feeling the stimulation was unknown as was any actions/interventions taken or resolution of the issue.There were no further complications reported or 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: 8205402
• MDR Text Key: 131768438
• Report Number: 3007566237-2018-03738
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P080025
• 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: 01/10/2019

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?: Yes
• 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: 12/30/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 74