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

Model Number ESPRIT S

Device Problem Pacing Problem (1439)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

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, during a follow-up, a pacing pause was observed on the monitoring ecg.The device was programmed in vvi mode at 60 min-1 without hysteresis.After the pause, there was an escape rhythm with a ventricular interval greater than 1400 ms (approximately 42 bpm).

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during a follow-up, a pacing pause was observed on the monitoring ecg.The device was programmed in vvi mode at 60 min-1 without hysteresis.After the pause, there was an escape rhythm with a ventricular interval greater than 1400 ms (approximately 42 bpm).

• 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: 11263557
• MDR Text Key: 230688598
• Report Number: 1000165971-2021-00255
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527009179
• UDI-Public: (01)08031527009179(11)160701(17)180201
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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 Expiration Date: 02/01/2018
• Device Model Number: ESPRIT S
• Device Catalogue Number: ESPRIT S
• Device Lot Number: S0199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1