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

Model Number 3531

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Erosion (1750)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 305901, lot# unknown, product type: screening device.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was implanted with an external neurostimulator.It was reported that the patient had a 1-week basic evaluation and the programmer was not working.When the healthcare professional (hcp) went to pull the leads out, the bandage was lifted, it was indicated that the right and left leads were both broken.On the right side, half of the lead was sticking out of the skin and the other half was attached to the grounding pad.The hcp was able to remove the entire lead from under the skin.On the left side, the broken half of the lead was attached to the grounding pad and the other half that travels under the skin was missing.The hcp was unable to indicate if it was still under the skin.The patient was unable of how the leads were broken; the patient was wearing a bandage over the leads.An x-ray was ordered; the results are still pending at the time of this report.There were no further complications or anticipations reported with this event.

• 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: 7283102
• MDR Text Key: 100664131
• Report Number: 3007566237-2018-00503
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2018

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: 01/31/2018
• Initial Date FDA Received: 02/20/2018
• 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: 66 YR