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

Model Number MDT-IPG

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Muscle Weakness (1967); Pleural Effusion (2010); Dizziness (2194)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

A voluntary medwatch form 3500 was received (report # mw5153211); 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 patient experienced shortness of breath.An x-ray was performed and a pleural effusion was noted.An electrocardiogram (ecg) was performed and the patient was admitted to hospital with exacerbation of heart failure symptoms;  fatigue, weakness and dizziness.The leadless implantable pulse generator (ipg) was noted to be defective and was attempted to be explanted.However, due to difficulties in removing, the leadless ipg was remains inactivated in the patient and was replaced. no further 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 IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19114424
• MDR Text Key: 340228014
• Report Number: 9612164-2024-01821
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2024

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: Lay User/Patient
• Device Model Number: MDT-IPG
• Device Catalogue Number: MDT-IPG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/16/2024
• 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 Outcome(s): Required Intervention; Hospitalization