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

Model Number ALIZEA DR 1600

Device Problems Misconnection (1399); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

On (b)(6) a 2013 pacemaker was replaced with the alizea (b)(6).On november 6th 2023, the patient was reoperated for possible capture failure in the rv lead, but the (b)(6) indicated that there was a failure in the connection of the right ventricular lead and that the connection screw did not ratchet.The pacemaker has been replaced.

Manufacturer Narrative

The conclusions are as follows: the electrical characteristics of the returned device conformed to established specifications.Upon reception of the device, pacing pulses were generated appropriately by the device.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.Atrial and ventricular setscrews were found completely unscrewed.The ventricular one is rotated 180°.The user has probably completely unscrewed the setscrews then removed the screwdriver.Afterwards, he was not able to reposition the setscrews.In addition, no obvious tightening marks on the atrial and the ventricular setscrew tips were noted.Those observations indicate an incorrect/ incomplete lead connection to the pacemaker at both channels and therefore could explain the capture failure described in the complaint, as well as, the fact that the physician did not hear the ratchet¿s sound.- based on the available data, no issue is suspected on the subject pacemaker.For more details, please refer to the attached analysis report.

Event Description

On (b)(6) 2013 pacemaker was replaced with the alizea ((b)(6)).On (b)(6) 2023, the patient was reoperated for possible capture failure in the rv lead, but the physician indicated that there was a failure in the connection of the right ventricular lead and that the connection screw did not ratchet.The pacemaker has been replaced.

• 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: 18267093
• MDR Text Key: 329731310
• Report Number: 1000165971-2023-01003
• 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,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• 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