MAUDE Adverse Event Report: MICROPORT CRM S.R.L. ALIZEA; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	ALIZEA DR 1600
Medical Device Problem Codes	Premature Discharge of Battery (1057); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, microport crm rep (b)(6) called technical services stating that he was performing an in-clinic interrogation of alizea dr (b)(6).Upon interrogation, a warning message stating "rrt occurred on (b)(6) 2024.Magnet rate 80" is displayed.(b)(6) states the device is found programmed in vvi mode and is displaying the current battery voltage value to be 3.12v.
Additional Manufacturer Narrative
The preliminary analysis led to the following observations: the patient files analysis has revealed that the rrt (recommended replacement time) warning has been displayed following a low battery voltage measurement performed with the ble (bluetooth low energy) function.Nevertheless, a battery voltage measurement was performed later without this ble function indicating a correct value (3.10 v).This issue is due to the ble function.The associated risk is a pacemaker reset which could lead to a switch in back-up mode with the impossibility to re-initialize it correctly inducing a device¿s interrogation impossibility.Nevertheless, the back-up mode is a safety mode where the pacemaker operates with the following parameters: vvi, 70 min-1, 5 v, 0.5 ms, sensitivity 2.2 mv, unipolar.Therefore, the pacing is still delivered.However, the device¿s integrity, cannot be guaranteed anymore.Based on the available data, a component failure (involved in the ble function) is currently suspected.Therefore, it is recommended to replace this pacemaker.In case the device is replaced and returned, a device¿s expertise will be performed such as visual check, electrical status check at reception, electrical tests and imaging in order to determine the root cause.Please refer to the analysis report.
Event or Problem Description
On december 19, 2024, microport crm rep (b)(6) called technical services stating that he was performing an in-clinic interrogation of alizea dr (b)(6).Upon interrogation, a warning message stating "rrt occurred on march 25, 2024.Magnet rate 80" is displayed.(b)(6) states the device is found programmed in vvi mode and is displaying the current battery voltage value to be 3.12v.
Additional Manufacturer Narrative
The conclusions are as follows: the rrt warning has been raised due to bluetooth communication issue.The battery is not able to provide the needed current for a bluetooth communication.O a component involved in the current collection for a bluetooth communication has been found broken through battery's x-ray (see picture below).This complaint is recorded for trending purposes.For more details, please refer to the attached analysis report.
Event or Problem Description
On (b)(6), during an in-clinic interrogation of alizea dr (b)(6), a warning message stating "rrt occurred on (b)(6) 2024.Magnet rate 80" is displayed.The device is found programmed in vvi mode and is displaying the current battery voltage value to be 3.12v.

• Brand Name: ALIZEA
• Common Device Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 21179847
• Report Number: 1000165971-2025-00045
• Device Sequence Number: 4222631
• Product Code: DXY
• UDI-Device Identifier: 08031527018997
• UDI-Public: (01)08031527018997(11)231019(17)260419
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2026
• Device Model Number: ALIZEA DR 1600
• Device Catalogue Number: TPM020U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 03/13/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 01/21/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic