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 Code	Pain (1994)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 978a128, lot#: va27qup, implanted: (b)(6) 2020, explanted:(b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 978a128, serial/lot #: (b)(4), ubd: 09-feb-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 (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).The patient reported significant pain right after surgery in their left buttocks/sciatic nerve, that goes down their leg.This occurred before any therapy had been turned on.The healthcare professional (hcp) gave them some extra numbing medicine post surgery and then some pain meds to go home with.The device had since been turned up on (b)(6) 2020 and the patient said that their pain was still there as of (b)(6) 2020, but not related to the device now being turned on.Surgical intervention was planned to occur on (b)(6) 2020.There were no device issues reported, and no further patient complications reported at this time.Additional information was received from a manufacturer representative (rep).The rep reported that the patient did have some sciatic nerve issue on their left side prior to implant.They had tried turning the device off and then back on.On (b)(6) 2020 the patient reported that the pain was now positional and that it had improved, but had not gone away.It was unknown at the time whether surgical intervention would be taken to remove the device, but it would be determined on (b)(6) 2020 on their scheduled surgery date for their stage 2 procedure.Additional information was received from a manufacturer representative (rep).The rep reported that the patient's pain got better as time went on.However, the physician decided to move the lead to the other side and place the battery all on the right side to avoid the left side altogether due to the patient's sciatic pain on their left side.

• 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: 10750642
• Report Number: 2182208-2020-02555
• Device Sequence Number: 11244394
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Device Lot Number: NLM357172N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 56