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

Model Number 353101

Device Problems Break (1069); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Stretched (1601); Communication or Transmission Problem (2896); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id neu_unknown_lead lot# serial# unknown implanted: explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a trial patient who was using an external neurostimulator (ens) for urge incontinence and urgency frequency.Their trial start date was (b)(6) 2024.It was reported that the patient's lead was not connected and the patient was experiencing a loss of stimulation as a result.Troubleshooting was performed but communication was lost on the programmer.Additionally, the patient was experiencing pain.It is unknown if the issues were resolved.On (b)(6) 2024, the patient stated the leads had been stretched, curled, and frayed causing their device to no longer function.The patient believes they may have tugged on it too much while at a funeral on (b)(6) 2024.

Event Description

Additional information was received from a healthcare professional (hcp).The hcp reported that the patient complained of their leads being loose and getting in their way, so they cut them.They then went to the doctors office and had them pulled the same day.The leads were pulled on (b)(6) 2024.The patient was scheduled for an mri.The patient was seen by the nurse practitioner on (b)(6) 2024.The patient had their stage 2 implanted placed on (b)(6) 2024.They confirmed the issue was resolved.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; ceiba norte industrial park; minneapolis,mn PR 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; ceiba norte industrial park; minneapolis,mn PR 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19068066
• MDR Text Key: 340350635
• Report Number: 3004209178-2024-08692
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/08/2024
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 53 KG