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

Model Number 353101

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/07/2018

Event Type  malfunction  

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 patient with an external neurostimulator for fecal incontinence.It was reported that there was a possible lead damage during the advance evaluation.When the healthcare professional (hcp) was bringing up the boot over the lead extension set screw housing, the insulation portion of the lead body pulled away slightly.It was noted that the hcp was following standard recommendations and was not putting any added stress on the lead when it occurred.The patient alleges possible lead issues that caused the issue.On (b)(6) 2018, it was reported that the patient had voided twice at night, which she has never done before.She also stated she went to a healthcare professional (hcp).There were no further complications or anticipations reported with this event.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3889-33, lot# va1r8al, implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an external neurostimulator for fecal incontinence.It was reported that there was a possible lead damage during the basic evaluation.When the healthcare professional (hcp) was bringing up the boot over the lead extension set screw housing, the insulation portion of the lead body pulled away slightly.It was noted that the hcp was following standard recommendations and was not putting any added stress on the lead when it occurred.The patient alleges possible lead issues that caused the issue.On (b)(6) 2018, it was reported that the patient had voided twice at night, which she has never done before.She also stated she went to a healthcare professional (hcp).There were no further complications or anticipations reported with this event.

• 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: 7664937
• MDR Text Key: 113272246
• Report Number: 3007566237-2018-02000
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• 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: 07/05/2018

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: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 07/05/2018
• 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: 51 YR