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

Model Number ENO DR

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

Device appears to have failed autolaunch with atrial lead staying in unipolar functioning despite in person interrogation showing no issues with the bipolar functioning.Why has autolaunch not completed and rolled to biploar.The failure to swap to bipolar also caused atrial undersensing as the unipolar atrial sensitivity was set to 1 mv.

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.

Manufacturer Narrative

Patient files were provided but not at the time where the issue occurred.We are awaiting for the missing patient files.Based on the files provided, for now, no issue is suspected on the subject pacemaker.

Event Description

Device appears to have failed autolaunch with atrial lead staying in unipolar functioning despite in person interrogation showing no issues with the bipolar functioning.Why has autolaunch not completed and rolled to biploar.The failure to swap to bipolar also caused atrial undersensing as the unipolar atrial sensitivity was set to 1 mv.

• Brand Name: ENO DR
• 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
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 15834311
• MDR Text Key: 304985390
• Report Number: 1000165971-2022-00527
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2022

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 Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic