MAUDE Adverse Event Report: MICROPORT CRM S.R.L. ALIZEA DR 1600; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number ALIZEA DR 1600

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

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

Event Date 12/07/2022

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 sorin that was cleared or approved by fda for marketing in the united states.After re-intervention on (b)(6) 2022: a connection issue was confirmed.The physician tried again to connect the lead to the device and everything went well.No issue is suspected on the subject pacemaker.

Event Description

The pacemaker was implanted with a medtronic 3830-69 ventricular lead for left bundle branch pacing.After closure of the wound, the pacemaker is interrogated and the ventricular electrode indicates an impedance greater than 3000.Several measurements are made after various maneuvers and a normal impedance is obtained continuously.Yesterday the patient went to the pacemaker revision and an impedance greater than 3000 was continuously obtained.She is scheduled for reoperation on (b)(6) 2022.The doctor does not know if it is a broken lead or a connection failure after re-intervention on (b)(6) 2022: a connection issue was confirmed.The physician tried again to connect the lead to the device and everything went well.

• Brand Name: ALIZEA DR 1600
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 16003814
• MDR Text Key: 305845643
• Report Number: 1000165971-2022-00594
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic