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 Pacing Inadequately (1442)

Patient Problems Dyspnea (1816); Dizziness (2194); Discomfort (2330)

Event Date 09/03/2021

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

The subject reply crt-p was implanted on (b)(6) 2020.Reportedly, the patient is very sportive and has a persistent atrial fibrillation with av node ablation and biventricular pacemaker implantation.The patient reported inadequate pacing frequency.During the follow-up performed on (b)(6) 2021, test exercise procedures were performed.The first was to climb 1-5 flights of stairs and the device was programmed as follows: mv only, very low, 165 bpm.The patient came back with dyspnea.The patient was interrogated in a lying down position and the rate was 85 bpm.The patient was completely breathless and the breathing frequency increased.After several minutes the pacemaker rhythm increased to 165 bpm and the patient was in recovery phase.The second test was performed in twin trace, very low, 165 bpm.The patient was interrogated in a lying down position and the rate was 75 bpm.The patient needed support by manually increasing the basic rate.The third test was 50 squats.The device was programmed as follows: mv only, very low, 155 bpm (basic rate 70).The rate after the exercise was 75 bpm.The same test was repeated with twin trace and the patients rate after the exercise was 75 bpm.The physician decided to leave the pacemaker programmed with g only and very low.Preliminary analysis revealed that between (b)(6) 2020, the response was aligned with the programmed parameters.

Event Description

The subject reply crt-p was implanted on (b)(6) 2020.Reportedly, the patient is very sportive and has a persistent atrial fibrillation with av node ablation and biventricular pacemaker implantation.The patient reported inadequate pacing frequency.During the follow-up performed on (b)(6) 2021, test exercise procedures were performed.The first was to climb 1-5 flights of stairs and the device was programmed as follows: mv only, very low, 165 bpm.The patient came back with dyspnea.The patient was interrogated in a lying down position and the rate was 85 bpm.The patient was completely breathless and the breathing frequency increased.After several minutes the pacemaker rhythm increased to 165 bpm and the patient was in recovery phase.The second test was performed in twin trace, very low, 165 bpm.The patient was interrogated in a lying down position and the rate was 75 bpm.The patient needed support by manually increasing the basic rate.The third test was 50 squats.The device was programmed as follows: mv only, very low, 155 bpm (basic rate 70).The rate after the exercise was 75 bpm.The same test was repeated with twin trace and the patients rate after the exercise was 75 bpm.The physician decided to leave the pacemaker programmed with g only and very low.Preliminary analysis revealed that between (b)(6) 2020 and (b)(6) 2020, the response was aligned with the programmed parameters.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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: 12566351
• MDR Text Key: 274429197
• Report Number: 1000165971-2021-00663
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: REPLY CRT-P
• Device Catalogue Number: REPLY CRT-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• 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