MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number W4TR01

Device Problem Failure to Interrogate (1332)

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

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: mc1avr1 leadless pacemaker, implanted (b)(6) 2022 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient has a leadless implantable pulse generator (ipg) and, in addition, underwent implant of a cardiac r esynchronization therapy pacemaker (crt-p)).There was telemetry for the entire implant and connection was strong until the physician connected the leads to the crt-p.Wireless connection to the device was lost with the mobile programmer.The session was ended and the tablet was powered off.The system was rebooted and then the same issue occurred.The programmer remained connected to the leadless ipg.The device was then connected again with the tablet.Vectors were then tested and then the signal was lost again.Once the patient was taken to their room, a legacy programmer was able to successfully connect to the device and the device could be programmed and tests run.The programmer seemed to be the best way to maintain connection and complete testing/programming, but wireless connection cannot be established.Six days after implant, telemetry was able to be maintained with the device and the programmer.The leadless implantable pulse generator (ipg) was inactivated and the crt-p device remains in use.The mobile programmer remains in use.No patient complications have been reported as a result of this event.

• Brand Name: PERCEPTA QUAD CRT-P MRI SURESCAN
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16108413
• MDR Text Key: 308399430
• Report Number: 9614453-2023-00057
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169891418
• UDI-Public: 00643169891418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2023

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 Expiration Date: 03/28/2024
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/05/2023
• Date Device Manufactured: 10/13/2022
• 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
• Treatment: 459878 LEAD, 407658 LEAD, 407652 LEAD
• Patient Age: 89 YR
• Patient Sex: Male