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

Model Number 3531

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erythema (1840); Unspecified Infection (1930); Discomfort (2330); Fluid Discharge (2686); Test Result (2695)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3889-33, lot# va1mwb4, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 3889-33, serial/lot #: va1mwb4, (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient with an external neurostimulator (ens) for advanced evaluation.It was reported that the patient had an infection at the pocket site and lead insertion site following their stage 1 procedure.There were no known contributing factors and it was reported that the issue was resolved at the time of the report.The lead wire had been disposed of and the culture of the pocket incision was taken and sent to the lab for further analysis.The patient underwent lead implantation procedure on (b)(6) 2018 for bowel incontinence.Over the course of the evaluation period, they reported an 85-90% improvement in bowel symptoms.They reported discomfort at the pocket site during a visit with the physician on (b)(6) 2018.The implanting physician did not observe any external signs of infection.The physician sent a blood sample in which demonstrated higher than average crp, but normal white blood cell count.The morning of the patient's scheduled stage 2 procedure, the patient stated the discomfort had dissipated.Once they were positioned for surgery, it was observed that both of their incisions from stage 1 (pocket site and lead insertion site) were red.The lead insertion had a minor amount of cloudy fluid emerging.The physician aborted the stage 2 and immediately removed the lead wire and associated extension wire.Cloudy fluid was removed from the pocket site and sent for culture.Initial results demonstrated an infection for bacteria on the skin.During the stage 1 procedure, the implanting physician used a chloropep solution and an ioban sheet.No further complications were reported or anticipated.

• Brand Name: VERIFY
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7506288
• MDR Text Key: 107975603
• Report Number: 3007566237-2018-01419
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

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
• Device Operator: Health Professional
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 66