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 Urinary Retention (2119); Complaint, Ill-Defined (2331); Test Result (2695)

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 regarding a trial patient who was using an external neurostimulator (ens) for ¿bladder and bowl, but not for stool.¿ it was noted that the patient had the trial last week.They stated that it started on friday, and then they thought it was earlier in the week; they couldn¿t remember the day the trial started.It was stated that they had a pretty good stream before the trial.It was reported that during the first day their sodium got real low, and they ¿couldn¿t urinate no more¿ so they put a catheter in them during the trial.They didn¿t have too good of a stream, sometimes it would dribble out and other times it would shoot everywhere.The patient did not think they got 50% relief during the trial, but it was better than not going.During the first day they got low sodium, so they took a tolvaptan pill that makes them urinate.¿took first day when took cath out but still had wires in back.¿ the patient stated that they took the cath out on (b)(6) 2018, and took the wires out on (b)(6) 2018.It was stated that they urinated good that day and second day they ¿got a weak stream and all;¿ a couple of times they didn¿t think they were going to go.They also noted not having a good ¿scream¿ after they took the wires out.The patient then offered this timeline: they took tolvaptan on tuesday and it went pretty well; tuesday was erratic streams, not too good; monday wasn¿t too good; the trial was four days and they took the cath out on the fifth day; they got the trial on a friday and then they were saying they got it on tuesday.They were very confused about the dates things occurred and said they had it all scribbled on their calendar.Then patient stated that they were supposed to get the permanent device on (b)(6), and they wanted to know if it would be better than the trial.It was recommended that they follow up with their healthcare provider to discuss the results of the trial and if the implant is for them.There were no device issues reported, and no further patient complications are anticipated or expected 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: 7655005
• MDR Text Key: 112882690
• Report Number: 3007566237-2018-01946
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/02/2018

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: 06/28/2018
• Initial Date FDA Received: 07/02/2018
• 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): Required Intervention