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

Model Number ESPRIT DR

Device Problem Device Displays Incorrect Message (2591)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

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

On (b)(6) 2011, the subject pacemaker was implanted with non-microport leads.On (b)(6) 2020, during a follow-up, the battery impedance was 9.7 kohm.It was assumed that the pacemaker had reached the recommended replacement time (rrt), but the nurse was concerned about the following points: - a security warning was displayed in the summary screen but without any message nor in aida.- no estimated longevity of battery was displayed - it was programmed in vvi mode but with ventricular output at 2.5 v.

Event Description

On (b)(6) 2011, the subject pacemaker was implanted with non-microport leads.On 10 december 2020, during a follow-up, the battery impedance was 9.7 kohm.It was assumed that the pacemaker had reached the recommended replacement time (rrt), but the nurse was concerned about the following points: a security warning was displayed in the summary screen but without any message nor in aida.No estimated longevity of battery was displayed it was programmed in vvi mode but with ventricular output at 2.5 v the pacemaker was explanted on (b)(6) 2021.

Manufacturer Narrative

Please refer to the attached analysis report.

Manufacturer Narrative

The preliminary analysis of the provided information did not reveal any irregularities with the subject device.

Event Description

On (b)(6), the subject pacemaker was implanted with non-microport leads.On 10 december 2020, during a follow-up, the battery impedance was 9.7 kohm.It was assumed that the pacemaker had reached the recommended replacement time (rrt), but the nurse was concerned about the following points: a security warning was displayed in the summary screen but without any message nor in aida.No estimated longevity of battery was displayed.It was programmed in vvi mode but with ventricular output at 2.5 v.The pacemaker was explanted on (b)(6) 2021.

• 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
• MDR Report Key: 11108181
• MDR Text Key: 226064979
• Report Number: 1000165971-2021-00206
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESPRIT DR
• Device Catalogue Number: ESPRIT DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2020
• Event Location: Hospital
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1