MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CONNECTOR; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 24967

Device Problems Communication or Transmission Problem (2896); Computer Operating System Problem (2898)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during an implantable device interrogation with the mobile programmer patient connector when updating the date of birth (dob) field the mobile programmer application froze and lost connection to the implantable device three times.It was further reported that when the connection to the implantable device was lost the connection to the tablet supporting the mobile programmer was also lost.No patient complications have been reported as a result of this event.

• Brand Name: PATIENT CONNECTOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• 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: 12335705
• MDR Text Key: 267035268
• Report Number: 2182208-2021-03251
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00763000060428
• UDI-Public: 00763000060428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2021

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: Health Professional
• Device Model Number: 24967
• Device Catalogue Number: 24967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/18/2021
• Date Device Manufactured: 09/27/2019
• 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