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

Model Number 3531

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978)

Patient Problem Discomfort (2330)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3057, lot# unknown, product type: screening device.(b)(4) pertain to the lead.(b)(4) pertains to the lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a basic evaluation trial patient with an external neurostimulator (ens) for urge incontinence and urgency frequency.The patient reported that their tape was coming off and noted that it made them uncomfortable.The patient stated that they contacted their physician right away on the morning of report and was waiting to hear back.It was indicated that the tape had gotten stuck to the patient's clothing and that their daughter had tried to help re-tape the lead wires.Additional information was received from the patient on 2017-dec-31.The patient reported that they were still having issues with the tape and noted that they had not heard back from the doctor.The patient was doing their best to keep it taped and in place but thought it may have caused the wires to move.No further complications were reported or were expected.

• 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: 7200239
• MDR Text Key: 97963822
• Report Number: 3007566237-2018-00182
• 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: 01/17/2018

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: 12/29/2017
• Initial Date FDA Received: 01/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR