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

Model Number 353101

Device Problems Use of Incorrect Control/Treatment Settings (1126); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Device Displays Incorrect Message (2591); Application Program Problem (2880); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/30/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3889, lot#: unknown, product type: lead.Other relevant device(s) are: product id: 3889, 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 an advanced evaluation trial patient with an external neurostimulator (ens) for urgency frequency and urge incontinence.It was reported by an advanced evaluation patient¿s spouse that the programmer would not increase in stimulation and that it was giving them a message of maximum settings have been reached.Troubleshooting was not effective so the caller was referred to patient services.While speaking with patient services, it was reported the patient was seeing settings not available on the controller.The caller stated on saturday the wires pulled out of the patient¿s back a little bit and it was bleeding a little.It was reviewed that a health care physician (hcp) or manufacturer representative (rep) could look at the wires to make sure they were in place and to help with settings.It was noted the patient¿s trial began on (b)(6) 2018.There were no further complications reported/anticipated.

Manufacturer Narrative

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

• 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: 7713871
• MDR Text Key: 115354029
• Report Number: 3007566237-2018-02191
• 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: 10/04/2018

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: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• 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: 66 YR