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

Model Number ENO DR

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2023

Event Type  malfunction  

Event Description

Reportedly, the physician suspects a fracture of the right ventricular lead due to the high impedance measured by the device and some noise recorded.A reintervention was occurred on (b)(6) 2024 and it was spotted that the lead was not correctly connected to the eno dr.The lead was reconnected to the pacemaker device and good parameters were obtained.

Manufacturer Narrative

The review of the quality documents confirmed a regular manufacturing of the device and the lead (not approved in the us).At the beginning of october 2023, a sudden increase in ventricular lead impedance values was observed, changing from value around 600 to values over 3000, associated with a loss of the ventricular capture.As shown on the x-ray picture provided, the rv is-1 lead pin did not protrude beyond the connector.According to the field, a reintervention was performed on 29 january 2024, and it was found that the ventricular xfine lead was not well connected to the pacemaker.This founding explains the electrical issues observed (high ventricular impedance and the loss of the ventricular capture).The physician reconnected the lead to the pacemaker which resolved the reported electrical issue.It should be noted that upon lead insertion into its associated port, it is important to verify that the lead tip protrudes behind the connector port, prior any screwing operation, to ensure appropriate connection of the lead by screwing the setscrew, and screwing operation prior full insertion of the lead into the port may contribute to a lead connection issue.Based on available data, no issue is suspected on the subject pacemaker or on the lead.This complaint has been recorded for trending purposes.

Event Description

Reportedly, the physician suspects a fracture of the right ventricular lead due to the high impedance measured by the device and some noise recorded.A reintervention was occurred on 29/01/2024 and it was spotted that the lead was not correctly connected to the eno dr.The lead was reconnected to the pacemaker device and good parameters were obtained.

• Brand Name: ENO
• 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: 18787691
• MDR Text Key: 337422624
• Report Number: 1000165971-2024-00174
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(17)300325(11)300323
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENO DR
• Device Catalogue Number: TPM014C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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