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

Model Number ALIZEA DR 1600

Device Problems Difficult to Interrogate (1331); Pacemaker Found in Back-Up Mode (1440)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

Device cannot be interrogated.They tried both with an orchestra plus and a smarttouch.The programmer delivered a message telling them to contact technical service.I am planning to visit the centre this friday (16th september).The patient will be there and i will be able to try another interrogation.I will also retrieve data from the programmer if available.Following the follow up of 16th september : i could interrogate it without problem.But, it was 70lpm, 5v output, unipolar both detection and pacing.I retrieved the expert files and will send them later.It seemed that at some point the device switched to nominal value.I do not know if it was an unintentional click on the cross button or a problem with the device that made it switch by itself.

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.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Device cannot be interrogated.They tried both with an orchestra plus and a smarttouch.The programmer delivered a message telling them to contact technical service.I am planning to visit the centre this friday (16th september).The patient will be there and i will be able to try another interrogation.I will also retreive data from the programmer if available.Any clue before friday would be appreciated.Following the follow up of 16th september : i could interrogate it without problem.But, it was 70lpm, 5v output, unipolar both detection and pacing.It seemed that at some point the device switched to nominal value.I do not know if it was an unintentional click on the cross button or a problem with the device that made it switch by itself.Any light you can shed on the issue will be welcomed.

• 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: 15493169
• MDR Text Key: 300710669
• Report Number: 1000165971-2022-00421
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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
• Date Manufacturer Received: 09/28/2022
• 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
• Patient Ethnicity: Non Hispanic