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

Model Number REPLY DR

Device Problem High Capture Threshold (3266)

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

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

Please refer to the attached investigation report.

Event Description

A patient was implanted with dual chamber reply dr pacemaker (sn (b)(6)) and two leads (atrial s/n (b)(6) and ventricular s/n (b)(6)) by the auxiliary vein on (b)(6) 2020.On (b)(6) 2023, the test parameters of the program-controlled pacemaker were not ideal, the ventricular capture threshold was high, and the suspected ventricular lead was observed under the image, so the director suggested going to beijing for treatment.On (b)(6) 2023 a reintervention occurred and the involved ventricular lead and the pacemaker were replaced by devices from another companies.

• 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: 17690817
• MDR Text Key: 322738066
• Report Number: 1000165971-2023-00690
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• 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