MAUDE Adverse Event Report: MEDTRONIC, INC. MYCARELINK PATIENT MONITOR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 24952B

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 02/01/2024

Event Type  malfunction  

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that the patient experienced a shock when the reader was put over the device.The patient had also been getting little zaps for the last month.Discussed usage of the remote monitor.Warm transferred the patient back to the customer representative for further advise with the reader and referred to the doctor regarding the symptoms incurred.No troubleshooting taken.The monitor remains in use.No patient complications have been reported as a result of this event.

• Brand Name: MYCARELINK PATIENT MONITOR
• 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: 19005882
• MDR Text Key: 338938390
• Report Number: 2182208-2024-01397
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00763000113797
• UDI-Public: 00763000113797
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• 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
• Report Date: 03/29/2024

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: 24952B
• Device Catalogue Number: 24952B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2024
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female