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 No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

During a pacemaker replacement procedure, the subject pacemaker could reportedly not be connected to the already implanted leads due to a screwing issue.

Manufacturer Narrative

The preliminary analysis of the returned device suggests that the issue was caused by user-incurred damage to the ventricular setscrew.

Event Description

During a pacemaker replacement procedure, the subject pacemaker could reportedly not be connected to the already implanted leads due to a screwing issue.

Event Description

During a pacemaker replacement procedure, the subject pacemaker could reportedly not be connected to the already implanted leads due to a screwing issue.

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: 9546680
• MDR Text Key: 178321945
• Report Number: 1000165971-2020-00212
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(11)190925(17)210925
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2020

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 Expiration Date: 09/25/2021
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2019
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 01/22/2020; 03/10/2020
• Supplement Dates FDA Received: 02/19/2020; 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1