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

Model Number ALIZEA DR 1600

Device Problems Electromagnetic Compatibility Problem (2927); Reset Problem (3019)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2023

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 subjected device was implanted on (b)(6) 2023.On 20 march a remote alert was received, indicating a device reset and a technical issue occurred on (b)(6) 2023 during in-house follow-up on (b)(6) 2023 the warning messages were confirmed but normal device function was observed.On 8 april 2023 another remote alert was received, indication a technical issue on the device with occurrence on (b)(6) 2023.

Manufacturer Narrative

Overconsumption leading to a premature battery depletion has been observed.This overconsumption is triggered by electromagnetic interferences (emi) induced by an electrocautery use during the implantation procedure, very close to the concern device and in a very specific phase of the automatic implantation detection: within five minutes after the ventricular lead connection confirmation.Electrocautery is not recommended once the device is in the pocket since it cannot be used far from the pacemaker.At reception, the device has been opened and deeply analysed.The pacemaker protections against emi have been tested and confirmed working as intended.No device failure has been confirmed.However, this complaint is recorded for trending purpose to assess the need to implement any improvement.

Event Description

Reportedly, the subjected device was implanted on (b)(6) 2023.On (b)(6) a remote alert was received, indicating a device reset and a technical issue occurred on (b)(6) 2023 during in-house follow-up on (b)(6) 2023 the warning messages were confirmed but normal device function was observed.On (b)(6) 2023 another remote alert was received, indication a technical issue on the device with occurrence on (b)(6) 2023.

• 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: 16843062
• MDR Text Key: 314272438
• Report Number: 1000165971-2023-00371
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P950029
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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