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 Failure to Interrogate (1332)

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

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr 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

During the implantation of the subject crt-p on (b)(6) 2021, the physician did not observe any particular problem during the procedure.During his check-up before the patient was discharged from surgery, he was unable to communicate with the device and to check its correct operation with an orchestra+ programmer.After several complete restarts of the programmer, verification of the correct positioning of the cpr3 head (which had several leds lit), it was impossible to communicate with the device.He observed the same malfunction when using a smartouch programmer.He therefore decided to re-intervene on the patient and replace the subject device with another brand device.After explantation, it was possible to communicate with the pacemaker with the cpr3 head of the orchestra+ in contact with the device.Several other microport crm devices were implanted on the same day in this operating room with the same programmer without encountering any communication failure.

Event Description

During the implantation of the subject crt-p on (b)(6) 2021, the physician did not observe any particular problem during the procedure.During his check-up before the patient was discharged from surgery, he was unable to communicate with the device and to check its correct operation with an orchestra+ programmer.After several complete restarts of the programmer, verification of the correct positioning of the cpr3 head (which had several led's lit), it was impossible to communicate with the device.He observed the same malfunction when using a smartouch programmer.He therefore decided to re-intervene on the patient and replace the subject device with another brand device.After explantation, it was possible to communicate with the pacemaker with the cpr3 head of the orchestra+ in contact with the device.Several other microport crm devices were implanted on the same day in this operating room with the same programmer without encountering any communication failure.

• 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: 12093178
• MDR Text Key: 259203799
• Report Number: 1000165971-2021-00529
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 08031527014173
• UDI-Public: (01)08031527014173(11)201103(17)220603
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: REPLY CRT-P
• Device Catalogue Number: REPLY CRT-P
• Device Lot Number: S0470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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