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

Model Number	353101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 978b128, lot#: va28j9r, implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 14-apr-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding an advanced evaluation patient who was using an external neurostimulator (ens) it was reported that during the scheduled phase 2 procedure.The healthcare professional (hcp)  opened the pocket at the connection site and pus oozed out.Because of the pocket infection, the stage 2 procedure was cancelled and the lead was removed.The pocket was irrigated with antibiotic solution and sterile water.The patient was going to be continually treated for the infection by the physician.  once it completely heals, the patient was planned to be rescheduled for full implant.There were no device issues reported, and no further patient complications reported at this time.
Additional Manufacturer Narrative
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 or Problem Description
The hcp reported that patient was given antibiotic.No further complications were reported/anticipated at this time.

• Brand Name: VERIFY ENHANCED
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10663062
• Report Number: 2182208-2020-02322
• Device Sequence Number: 3316806
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR