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

Model Number ENO DR

Device Problems Difficult to Interrogate (1331); Pacemaker Found in Back-Up Mode (1440)

Patient Problem No Information (3190)

Event Date 03/31/2020

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.

Event Description

Reportedly, the patient had intermittent complete av block.During implantation, when the leads were connected to the pacemaker, normal pacing was observed at 60 min-1.However, a few minutes later, the device switched in vvi mode at 70 min-1 and unipolar pacing until the end of the procedure.The physician used electrocautery to close the pocket.After the procedure, interrogation of the pacemaker was not possible.The programmer continued to load for a while, with the word 'interrogation' at the top of the screen.As interrogation was not possible, and no buttons on the programmer could be pressed, the programmer was restarted.Upon re-interrogation of the pacemaker, a message stating that the device was in standby mode was displayed.After the user pressed 'ok', interrogation was still not possible.The red cross button on the programmer keyboard was then pressed and the pacemaker could be interrogated.

Event Description

Reportedly, the patient had intermittent complete av block.During implantation, when the leads were connected to the pacemaker, normal pacing was observed at 60 min-1.However, a few minutes later, the device switched in vvi mode at 70 min-1 and unipolar pacing until the end of the procedure.The physician used electrocautery to close the pocket.After the procedure, interrogation of the pacemaker was not possible.The programmer continued to load for a while, with the word 'interrogation' at the top of the screen.As interrogation was not possible, and no buttons on the programmer could be pressed, the programmer was restarted.Upon re-interrogation of the pacemaker, a message stating that the device was in standby mode was displayed.After the user pressed 'ok', interrogation was still not possible.The red cross button on the programmer keyboard was then pressed and the pacemaker could be interrogated.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: ENO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; parc d'affaires noveos 4 avenue reaumur; clamart 92140 ; FR 92140
• MDR Report Key: 9995619
• MDR Text Key: 189162656
• Report Number: 1000165971-2020-00369
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(11)191023(17)211023
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2021
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0406
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1