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

Model Number 3531

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Material Integrity Problem (2978)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: (b)(4), product id: 3057, lot# unknown, product type: screening device, (b)(4).Product id: neu_unknown, lot# unknown, product type: unknown, (b)(4).

Event Description

Information was received from a consumer regarding a patient with a basic evaluation trial device.It was reported the trial patient feels that the leads moved and the dressing came off and patient does not have as high of stimulation as before; the patient ¿upped¿ (increased) the stimulation and was able to feel it.No further complications were reported or are anticipated.

• 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: 6880450
• MDR Text Key: 88045307
• Report Number: 3007566237-2017-03967
• 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: 09/20/2017

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: 08/30/2017
• Initial Date FDA Received: 09/20/2017
• 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 Age: 73 YR