MAUDE Adverse Event Report: MICROPORT CRM S.R.L. ALIZEA DR 1600; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number ALIZEA DR 1600

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tachycardia (2095)

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, this patient was implanted with an alizea dr to replace an earlier pacemaker having reached it's recommended replacement time.After implantation, the pacemaker was programmed to the safer-r mode.The patient was paced faster than usual presenting with ddd alike behaviour.After several mode changes, the heart rate became normal and spontaneous r waves became sensed.We can't explain what happened.Preliminary analysis is suggestive for the user not giving the system enough time to stabilize.

Event Description

Reportedly, this patient was implanted with an alizea dr to replace an earlier pacemaker having reached it's recommended replacement time.After implantation, the pacemaker was programmed to the safer-r mode.The patient was paced faster than usual presenting with ddd alike behaviour.After several mode changes, the heart rate became normal and spontaneous r waves became sensed.We can't explain what happened.Preliminary analysis is suggestive for the user not giving the system enough time to stabilize.

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.Please find below the conclusion of the analysis provided to the subsidiary (sent by mail on 31/08/2022): "it can be seen that there was a long and ¿rapid¿ sequence of tests and re-programming (annotations in red in the first column correspond to the real time of the launch of each of these activities).Consequently, the time for the system to get in a ¿steady state¿ was limited furthermore: all along the test / reprogramming's r-wave amplitude was on the small side.Certain functionalities and internal parameters may get disabled / re-initialized during testing.There are a number of dynamic criteria / triggers proper to the safer mode that may cause a temporary switch / a prolonged stay in ddd.It¿s not possible to retrtrieve the status of these at any time / any beat.The same goes for the observed temporary increases of the pacing rate overall it seems, once the system came in a steady state, spontaneous r-waves were given priority over ventricular pacing (which of course is the aim of the safer mode) therefore no issue is suspected with the device.".

• Brand Name: ALIZEA DR 1600
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 14488669
• MDR Text Key: 292510769
• Report Number: 1000165971-2022-00234
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALIZEA DR 1600
• Device Catalogue Number: ALIZEA DR 1600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2022
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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