MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number MDT-IPG

Device Problems High impedance (1291); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

A voluntary medwatch form 3500 was received (report #mw5152534); since f10 is not contained on that form, select fields in section f have been populated by the manufacturer.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

It was reported that the implantable pulse generator (ipg) exhibited a intermittent high impedance value.It was noted that the ipg remains in use. no patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC IPG
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19057816
• MDR Text Key: 339559776
• Report Number: 2182208-2024-01500
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-IPG
• Device Catalogue Number: MDT-IPG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/08/2024
• 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