MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number REPLY CRT-P

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/12/2021

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

Event Description

Reportedly, when the first atrial sensing test is performed, no atrial markers are visible and no values are displayed.The same has been observed with several reply crt-p devices.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, when the first atrial sensing test is performed, no atrial markers are visible and no values are displayed.The same has been observed with several reply crt-p devices.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 12791193
• MDR Text Key: 280684006
• Report Number: 1000165971-2021-01509
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REPLY CRT-P
• Device Catalogue Number: REPLY CRT-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• 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