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

Model Number ENO DR

Device Problem Program or Algorithm Execution Problem (4033)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

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 microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the pacemaker did not program the atrial pacing and sensing to bipolar configuration after the confirmation of the implantation; this had to be done manually upon the first interrogation.In the automatic detection of implantation settings, atrial pacing was set in bipolar configuration in the box before the implantation.

Manufacturer Narrative

Preliminary analysis revealed that the device behaved within specifications.

Event Description

Reportedly, the pacemaker did not program the atrial pacing and sensing to bipolar configuration after the confirmation of the implantation; this had to be done manually upon the first interrogation.In the automatic detection of implantation settings, atrial pacing was set in bipolar configuration in the box before the implantation.

Manufacturer Narrative

D3 and g1 updated.Please refer to the attached analysis report.

Event Description

Reportedly, the pacemaker did not program the atrial pacing and sensing to bipolar configuration after the confirmation of the implantation; this had to be done manually upon the first interrogation.In the automatic detection of implantation settings, atrial pacing was set in bipolar configuration in the box before the implantation.

• 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
• MDR Report Key: 11385766
• MDR Text Key: 239767049
• Report Number: 1000165971-2021-00336
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(11)200928(17)220928
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0465
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2021
• Event Location: Hospital
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1