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

Model Number ALIZEA DR 1600

Device Problem Unable to Obtain Readings (1516)

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

Event Date 11/10/2022

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, the battery longevity was not displayed at the follow-up on (b)(6) 2022.The patient has been sent home after the pacemaker check.

Manufacturer Narrative

As no cso file dated of the 10th of november 2022 are available, rms data dated on (b)(6) 2022 were reviewed.In this file, the battery longevity is displayed and estimated to 7-10 years.Therefore, the absence of battery longevity display was temporary.The analysis of this data revealed also the data were reset on (b)(6) 2022.A duration of minimum 5 minutes is needed to recover enough data after a data reset, therefore the longevity estimation is unavailable during this time.The root cause of this issue could not be determined with certainty; probably the battery longevity was not displayed due to the data reset performed on (b)(6) 2022.Based on available data, no issue is suspected on this device.

Event Description

Reportedly, the battery longevity was not displayed at the follow-up on (b)(6) 2022.The patient has been sent home after the pacemaker check.

• Brand Name: ALIZEA
• 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 ; 146013665
• MDR Report Key: 15876296
• MDR Text Key: 304476914
• Report Number: 1000165971-2022-00545
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALIZEA DR 1600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2023
• 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