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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

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, during an implant attempt the ventricular lead could not be fully inserted into the port.When the subject pacemaker was replaced, the ventricular lead could be fully inserted.

Event Description

Reportedly, during an implant attempt the ventricular lead could not be fully inserted into the port.When the subject pacemaker was replaced, the ventricular lead could be fully inserted.

Manufacturer Narrative

Please refer to the attached investigation report.

• 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: 11379395
• MDR Text Key: 234952690
• Report Number: 1000165971-2021-00323
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017341
• UDI-Public: (01)08031527017341(11)200224(17)220224
• 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
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2021
• Event Location: Hospital
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1