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

Model Number ALIZEA DR 1600

Device Problems Blocked Connection (2888); Connection Problem (2900)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

Reportedly, during a reintervention due the right ventricular dislodgement, the lead has been disconnected from the pacemaker right ventricular connector.When the physician tried to reconnect the lead after repositioning, it was not possible to screw the ventricular lead into the corresponding connector.

Manufacturer Narrative

The device involved in this complaint was shipped by the center for analysis.However, the unit could not be located.Therefore, no expertise could be performed.- preventive actions were put in place to avoid reoccurrence of this issue.A possible hypothesis would be a blood infiltration which may have been incurred through repetitive insertion and removal of the associated screwdriver during the first connection to this pacemaker.This infiltration could have led to this difficulty to connect again a new lead to the ventricular connector as described in the complaint description (lot of clumps and biological residues).Please find attached, the corresponding report.H3 other text : device lost.

Event Description

Reportedly, during a reintervention due the right ventricular dislodgement, the lead has been disconnected from the pacemaker right ventricular connector.When the physician tried to reconnect the lead after repositioning, it was not possible to screw the ventricular lead into the corresponding connector.

• Brand Name: ALIZEA
• Type of Device: 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: 17360938
• MDR Text Key: 319391252
• Report Number: 1000165971-2023-00538
• Device Sequence Number: 1
• Product Code: DXY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: No
• 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