MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COMPIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMC2QQ

Device Problems Unable to Obtain Readings (1516); Communication or Transmission Problem (2896); Data Problem (3196)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

It was reported that, on the date of implant, the cardiac resynchronization therapy defibrillator (crt-d) did not take all of the automatic daily lead impedance measurements.On the following day, in-office lead impedance tests were taken and the device measured all impedances, which were within normal range for all leads.It was speculated that connection and re-connection during the implant procedure between the device and leads, which may have caused measurements to not be taken, or a higher priority feature was executing and prohibited the lower priority automatic daily lead impedance measurements from running.The device is still in use.No patient complications have been reported as a result of this event.Additional information received noted that the cardiac resynchronization therapy defibrillator (crt-d) interrogation report displayed question marks instead of a threshold value when the device feature that automatically monitors pacing threshold at period intervals is in monitor mode.The device remains in use.It was further reported from evaluation of the device data that the issue may have been caused by an intermittent telemetry drop out.The telemetry drop out may have been caused by a paced event occurring at the same time as a request for telemetry.The issue temporarily disrupts communication between the crt-d and the programmer head.

Manufacturer Narrative

Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.The device memory indicated pacing capture management of the left ventricle was missing/had invalid data.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.

• Brand Name: COMPIA MRI QUAD CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 19217313
• MDR Text Key: 341611967
• Report Number: 9614453-2024-01724
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DTMC2QQ
• Device Catalogue Number: DTMC2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• 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 Age: 85 YR
• Patient Sex: Male