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

Model Number ENO DR

Device Problem Missing Test Results (3267)

Patient Problem No Information (3190)

Event Date 04/09/2020

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, during the first interrogation after implantation of the subject pacemaker, the physician programmed patient data and device parameters, and performed pacing and sensing tests.However, the tests results turned out to be missing in the printout.Upon the second device interrogation, the test results could be successfully printed.

Manufacturer Narrative

Preliminary analysis results showed that the device behaved as specified.

Event Description

Reportedly, during the first interrogation after implantation of the subject pacemaker, the physician programmed patient data and device parameters, and performed pacing and sensing tests.However, the tests results turned out to be missing in the printout.Upon the second device interrogation, the test results could be successfully printed.

Manufacturer Narrative

Please refer to the attached analysis report.Attachment: [20200730 - file-2020-00990 - analysis and closure report - resp-2020-00730.Pdf].

Event Description

Reportedly, during the first interrogation after implantation of the subject pacemaker, the physician programmed patient data and device parameters, and performed pacing and sensing tests.However, the tests results turned out to be missing in the printout.Upon the second device interrogation, the test results could be successfully printed.

• 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: 10003990
• MDR Text Key: 189447534
• Report Number: 1000165971-2020-00373
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(11)191121(17)211121
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0413
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/16/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1