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

Model Number ENO DR

Device Problems Pacing Inadequately (1442); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

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 patient is pacemaker dependent with a sinus rhythm at 70 bpm.The leads were implanted with good measurements (5mv for the atrial detection).The leads were connected to the subject pacemaker; pacing was observed in both chambers.After the intervention, the pacemaker was interrogated which terminated the automatic implantation detection.Atrial sensing test revealed p-wave amplitude values at 3.06mv; however, the pacemaker was still pacing in the atrial channel.The pacing mode was reprogrammed to vdd and the pacemaker followed then the spontaneous atrial rhythm.The device was reprogrammed to ddd mode and normal pacing following p-wave could be observed.

Manufacturer Narrative

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

Event Description

Reportedly, the patient is pacemaker dependent with a sinus rhythm at 70 bpm.The leads were implanted with good measurements (5mv for the atrial detection).The leads were connected to the subject pacemaker; pacing was observed in both chambers.After the intervention, the pacemaker was interrogated which terminated the automatic implantation detection.Atrial sensing test revealed p-wave amplitude values at 3.06mv; however, the pacemaker was still pacing in the atrial channel.The pacing mode was reprogrammed to vdd and the pacemaker followed then the spontaneous atrial rhythm.The device was reprogrammed to ddd mode and normal pacing following p-wave could be observed.

• 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: 11483091
• MDR Text Key: 239775739
• Report Number: 1000165971-2021-00346
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(11)201006(17)221006
• 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: 08/31/2021

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: 10/06/2022
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0467
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1