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 Hemorrhage/Bleeding (1888); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Complaint, Ill-Defined (2331); Test Result (2695)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient with an external neurostimulator (ens ) for non-obstructive urinary retention.It was reported that the patient had the stage 1 procedure on (b)(6) 2018.There were no reported complications during the procedure.The patient was educated and provided all paperwork.The patient felt all 3 programs comfortably in their pelvic floor.They were admitted to the hospital on (b)(6) 2018 for inability to urinate.Manufacturer representative spoke with the patient's spouse on (b)(6) 2018 and they stated they determined the patient's potassium levels were low.There were no contributing factors, diagnostics or actions/interventions reported.It was reported that the issue was not resolved at the time of the report.Additional information was received.It was reported the patient was in the hospital, they felt the device was not working for them.Contributing factors, actions/interventions and resolution to the reported event were unknown.Additional information was received.The patient mentioned while in the hospital they had a catheter in, they mentioned the dressing on their incision site had blood or some type of leakage and was not changed at the hospital.No further complications were reported or anticipated.[relevant medical history: patient has a history of falls and difficulty walking].

• 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: 7624503
• MDR Text Key: 111835206
• Report Number: 3007566237-2018-01846
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2018
• Initial Date FDA Received: 06/21/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 76 YR