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

Model Number 353101

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Irritation (1941); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Malaise (2359); Sleep Dysfunction (2517)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an external neurostimulator (ens) for urge incontinence and urgency frequency.The patient stated that at the hospital the day prior they put tubes down their throat, which caused the patient to have coughing fits.They stated they could not sleep the night prior due to pain in their leg, hip and shoulder.Contributing factors were unknown.The issues were not resolved at the time of the report.Additional information was received.The patient reported they were not feeling good.They stated they were having problems with their bowels leaking.They stated they were having leaking as their underwear get caught in the belt.They did not know if the therapy was working.They were feeling stimulation in their hip on program 2 at 1.4ma.The patient also stated they would like the device removed as it was really irritating them and so was the tape.The patient noted they had been in a lot of pain the night prior and they thought they had an infection.Additional information was received.The healthcare provider reported that the patient had a history of uti.There were no notes in the patient's medical record stating any diagnostic procedures had been done with regard to infection during or after the time of the trial.They cause and actions taken to resolve the stimulation being felt in the hip were unknown.It was noted that when they had spoken with the patient, the patient had not complained of this.No further complications were reported or anticipated.

• Brand Name: VERIFY ENHANCED
• 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: 8914523
• MDR Text Key: 155016189
• Report Number: 3007566237-2019-01800
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/21/2019
• 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: 75 YR