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

Model Number 3531

Device Problems Loose or Intermittent Connection (1371); Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3057, lot# unknown, product type: screening device.Other relevant device(s) are: 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 consumer regarding a trial patient who was using an external neurostimulator (ens) for urge incontinence.It was noted that the patient¿s trial started on (b)(6) 2018.It was reported that the patient was really sore in their coccyx area of their buttocks as they had to poke around a lot to place the leads and use a lot of lidocaine.Then on (b)(6) 2018 the patient called their healthcare provider because they believed that their lead came loose.Their healthcare provider asked them to come back in that day to have the leads removed.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

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

• 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: 7678400
• MDR Text Key: 114144513
• Report Number: 3007566237-2018-02046
• 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,Followup
• Report Date: 10/05/2018

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?: Yes
• 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: 06/14/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/05/2018
• 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 Age: 72 YR