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

Model Number 3531

Device Problems Migration or Expulsion of Device (1395); Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

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.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; trial began (b)(6) 2017.It was reported the trial patient had some bleeding near bandage.On (b)(6) patient reported one of the leads has come out.Per patient her daughter took a look and both the lead and dressing have come out.There was a possible lead migration, the left lead might have come out and patient is now on right side.Patient¿s setting was at 2.6 mamps on right side but received a message on the controller reading, "cannot provide desired settings, call clinician." patient was advised to lower stim down from 2.6 to 2.5 mamps to clear the message of ¿cannot provide desired settings, call clinician¿ but it was unknown whether this was successful.Patient stated lead removal was scheduled for (b)(6) 2017.No further complications were reported or are anticipated.

Manufacturer Narrative

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

Event Description

Additional information received.Health care professional reported the left lead was left out and the device was set on the right lead.No further information reported.

• 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: 6879532
• MDR Text Key: 87881719
• Report Number: 3007566237-2017-03955
• 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,Followup
• Report Date: 09/28/2017

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
• Device Lot Number: UNKNOWN
• 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
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 09/28/2017
• 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 Weight: 69