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

Model Number 3531

Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported the patient was undergoing a basic evaluation where one of the bilateral leads was used as a cathode/anode and a ground pad was not used.After five days of benefit, stimulation stopped and the patient had no pulsing sensation.Less than 50% therapy relief was noted.An error message to contact the physician was displayed on the controller and it would not increase the current.Stimulation was decreased and then attempted to be increased again, but it was stuck at 3.3 ma.The patient was moved to the other side and then stimulation could not be increased above 0.1 ma on either lead.An impedance issue and ¿???¿ error were noted.The patient was to self-catheterize after this.Upon further investigation, it was determined that the ¿stiff¿ part of the lead that plugged into the red socket on the new cable had ¿sheared¿ through.It was stated this open circuit would trigger the verify¿s cut out.It was unknown if the trial was to be classified as successful and the patient may need to be re-tested.No further information was reported.A follow up report will be sent if additional information is received.

Manufacturer Narrative

Concomitant: product id neu_unknown_lead, product type lead.(b)(4).

• Brand Name: VERIFY
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4807790
• MDR Text Key: 5897945
• Report Number: 3007566237-2015-01492
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2015

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: Other
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/31/2015
• 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 Outcome(s): Required Intervention