MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number REPLY 200 SR

Device Problems Display or Visual Feedback Problem (1184); Pacemaker Found in Back-Up Mode (1440)

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

Event Date 07/19/2023

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

On (b)(6) 2023, the customs found an anomaly (reply 200 sr/sn:(b)(6) in the on-site medical inspection of the warehouse.The anomaly is as follows: 1.The programmer cannot read the information for the first time (other pacemaker models are normal); 2.The programmer cannot be read after multiple operations (1 minute (no information), 3 minutes and 15 seconds (no information).3.Reset (confirm) exit, restart the programmer to read the information (pacemaker name and serial number) for 5 minutes and 32 seconds and the programmer crashes and cannot continue the program.

Event Description

Msc received the waybill /(b)(6) pacemaker *173 sets.On 2023-07-20, the customs found an anomaly (reply 200 sr/sn:(b)(6)) in the on-site medical inspection of msc warehouse.The anomaly is as follows: 1.The programmer cannot read the information for the first time (other pacemaker models are normal); the programmer is shown in picture.2.The programmer cannot be read after multiple operations (1 minute (no information), 3 minutes and 15 seconds (no information)).The programmer still displays as shown in figure 1; it is normal to switch to other pacemaker models midway; 3.Reset (confirm) exit, restart the programmer to read the information (pacemaker name and serial number) for 5 minutes and 32 seconds, as shown in figure 2, and then the instant programmer crashes and cannot continue the program.

Manufacturer Narrative

Additional patient files have been received and therefore new analysis has been performed with the following conclusions: - the device has switched in standby mode most probably due to a crosstalk that had occurred between devices being in a too close vicinity of each other at the time of interrogation (potentially leading to data inconsistencies).- the subject device has been correctly reinitialized on 20th july 2023 and has not switched in standby mode since.- a new interrogation should be performed.In case of normal functioning has been correctly restored, it is considered that the device can be implanted.

Event Description

Msc received the waybill /trn36735009 pacemaker *173 sets.On 2023-07-20, the customs found an anomaly (reply 200 sr/sn:(b)(6) ) in the on-site medical inspection of msc warehouse.The anomaly is as follows: the programmer cannot read the information for the first time (other pacemaker models are normal); the programmer is shown in picture.The programmer cannot be read after multiple operations (1 minute (no information), 3 minutes and 15 seconds (no information)).The programmer still displays as shown in figure 1; it is normal to switch to other pacemaker models midway; 3.Reset (confirm) exit, restart the programmer to read the information (pacemaker name and serial number) for 5 minutes and 32 seconds, as shown in figure 2, and then the instant programmer crashes and cannot continue the program.

Manufacturer Narrative

The reason of this switch in standby mode cannot be determined since no patient files at that date are available (19 of july 2023).- the files dated of 1st of august 2023 have shown that the subject device has been correctly reinitialized on 20th july 2023 and has not switched in standby mode since.- the root cause could not be determined since the files dated of the event date are missing.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 17581255
• MDR Text Key: 321547369
• Report Number: 1000165971-2023-00634
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

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: REPLY 200 SR
• Device Catalogue Number: REPLY 200 SR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/20/2023
• Supplement Dates Manufacturer Received: 09/14/2023; 10/24/2023
• Supplement Dates FDA Received: 10/03/2023; 10/24/2023
• 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