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

Model Number ALIZEA DR 1600

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

The conclusions are as follows: the visual inspection did not reveal any abnormality.The analysis confirms that the connection system of the subject pacemaker functioned as specified using a duplicate torque-limiting screwdriver.Normal tightening marks were seen on the ventricular setscrew tip.Those tightening marks are most likely related to the first lead connection during the first intervention.The ventricular setscrew was found completely unscrewed.The associated glue bead which is present to avoid losing the setscrew was found cracked.This complete unscrewing performed to reposition the ventricular lead has most probably led to the impossibly to screw again the setscrew.Indeed, once the setscrew is completed unscrewed (out of its cavity) it is difficult to screw again.Based on the available data, no issue is suspected on the subject pacemaker.

Event Description

After ventricular lead repositionning, it is not possible to screw the ventricular lead in pacemaker.

• 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: 19098043
• MDR Text Key: 340810142
• Report Number: 1000165971-2024-00321
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• 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