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

Model Number 353101

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

Patient Problems Unspecified Infection (1930); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Sore Throat (2396); Alteration In Body Temperature (2682)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3057, lot#: unknown, product type: screening device.Product id: 3057, lot#: unknown, product type: screening device.Product id: 3057, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) and a consumer regarding a basic evaluation trial patient with an external neurostimulator (ens) for urge incontinence.The basic evaluation patient reported discomfort to the manufacturer representative (rep).The rep noted they had the patient switch lead sides and asked the patient to contact the health care physician (hcp).The rep continued that that the patient had told them as they were collecting the patient¿s voiding diary information that they were concerned that this device was possibly causing them to be physically cold and to have a sore throat.The rep again told the patient to call their hcp to provide them medical advice.On the same day, the patient spoke with support link and they reported that they had not been feeling well and that they had been bedridden since having the leads placed.The patient stated they thought they may have an infection.There were no further complications reported.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that they did not know the patient¿s weight or ens lot/serial number.They reported that they did not know of any external factors and/or if the patient actually had an infection.The rep reported that they had repeatedly told the patient to contact their health care physician (hcp) and that if they were concerned to go to the emergency room (er).The rep noted they had also asked the patient to turn off the device and stated that they believed that the patient was having their wires removed by the hcp in the clinic that day (on (b)(6) 2020) there were no further complications reported.

Manufacturer Narrative

Continuation of d11: product id: 3057; product type: screening device; product id: 3057; product type: screening device.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.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10047998
• MDR Text Key: 190816400
• Report Number: 2182207-2020-00196
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: 970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR