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

Model Number 3531

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Fatigue (1849); Incontinence (1928); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Burning Sensation (2146); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) via an advanced evaluation trial patient regarding an external neurostimulator (ens).Patient does not have cath on and stated they were up all night and they are at wits end.They are tired and have insomnia.They also mentioned having a bit of incontinence the day prior and they haven't felt stimulation since leaving the healthcare provider's (hcp) office.Three days later, patient increased stimulation too high on saturday and felt a burning sensation on their back.They were laying down later on and felt stinging.After realizing it could be related to stimulation, they decreased it to 1.5v and are feeling okay now; the patient will increase stimulation later.On (b)(6) 2017, patient said the bandage is coming apart and is waiting on their hcp's call to come into the office and get it taken care of.Two days later, patient has insomnia and wasn't sure if he documented it correctly.It was clarified that the patient was not using a catheter and they had retention.No further patient complicat ions have been reported as a result of this event.

• 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: 6810418
• MDR Text Key: 83236348
• Report Number: 3007566237-2017-03429
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017

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: No Information
• 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: 07/28/2017
• Initial Date FDA Received: 08/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR