MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION 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	Erythema (1840); Unspecified Infection (1930); Pain (1994)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 978b128, lot#: va2a26f, implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead; product id: 3560022, lot#: va28499, product type: extension.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 30-jun-2022, udi#: (b)(4) ; product id: 3560022, serial/lot #: (b)(4), ubd: 17-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 healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding a patient with an implanted neurostimulator (ins) for gastrointestinal /pelvic floor therapy.It was reported the patient¿s dressing kept coming off multiple times for duration of stage 1.Patient had stage 1 on (b)(6) 2020 but was not compliant with tracking symptoms on the diary, getting covid testing prior to stage 2 multiple times or showing up for post op care in hcp office for replacement of dressing.The patient was unable to get in for stage 2 until (b)(6) 2020 because of not getting covid tested and returning rep and office phone calls.Multiple phone calls were made to patient and patient¿s daughter from the rep and physician office to proceed to stage 2 with successful stage 1.The rep called the patient twice a day with minimal response over a 5 week period.The rep also set patient up for a follow up appointment because the dressing came off multiple times but patient did not show up for the appointment.Patient had pain and redness at pocket site.On (b)(6) 2020 patient came in for stage 2 but pocket site was infected when the site was opened.Patient was started on antibiotics, site flushed with antibiotic irrigation and packed with dressing.Issue is resolved in a sense that the infected product was removed but patient is getting treated for the infection.Plan is to do a full implant once fully treated and healed.

• Brand Name: VERIFY ENHANCED
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11008347
• Report Number: 2182207-2020-01486
• Device Sequence Number: 4396477
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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: 12/09/2020
• Initial Report FDA Received Date: 12/15/2020
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 85