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	Unspecified Infection (1930); Tachycardia (2095); Complaint, Ill-Defined (2331)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 978b128, lot#: va29v76, implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 15-jul-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 a manufacturing representative regarding an advanced evaluation trial patient who was using an external neurostimulator (ens) for urgency frequency and urge incontinence.On (b)(6) 2020, the patient reported that they were pretty 'out of it' after their surgery.They also said that they slept most of the following day.On (b)(6) 2020, the patient was admitted to the hospital with an elevated heart rate 120-130s.They had a full system removal in the or the following evening for a possible infection.The hospital was sending the lead and extension for cultures to test for the infection source.The issue was resolved at the time of the report.There were no device issues reported, and no further patient complications reported 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: 10788391
• Report Number: 2182208-2020-02665
• Device Sequence Number: 3644747
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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?: No
• 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: 11/02/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 122