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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

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 microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

The patient shows a slow escape rhythm.Reportedly, the device was reprogrammed in voo pacing mode before an mri exam.The patient was monitored via spo2 and an ecg.When entering the mri room, the ecg showed a ventricular pacing rate at 160min-1.As a result, the patient was taken out of the mri room, and a device interrogation was performed.Upon device interrogation, ventricular pacing in voo, with a pacing rate at 80min-1, was observed.As a result, the patient attempted once more to enter the mri room.Nevertheless, the ecg showed a pacing rate at 160min-1 again.It was decided to cancel the mri exam.Preliminary analysis confirmed proper ventricular pacing operation before and after the first attempt to perform an mri scan.The elevated pacing rhythm displayed on the external ecg could have resulted from t-wave oversensing.

Event Description

The patient shows a slow escape rhythm.Reportedly, the device was reprogrammed in voo pacing mode before an mri exam.The patient was monitored via spo2 and an ecg.When entering the mri room, the ecg showed a ventricular pacing rate at 160min-1.As a result, the patient was taken out of the mri room, and a device interrogation was performed.Upon device interrogation, ventricular pacing in voo, with a pacing rate at 80min-1, was observed.As a result, the patient attempted once more to enter the mri room.Nevertheless, the ecg showed a pacing rate at 160min-1 again.It was decided to cancel the mri exam.Preliminary analysis confirmed proper ventricular pacing operation before and after the first attempt to perform an mri scan.The elevated pacing rhythm displayed on the external ecg could have resulted from t-wave oversensing.

Manufacturer Narrative

Review of the provided patient files confirmed proper ventricular pacing operation before and after the first attempt to perform an mri scan.In-house investigation could not reproduce the reported elevated pacing rate when placing a test reply crt-p in presence of a 400mt magnet.Based on available data, the origin of the reported behavior could not be determined with certainty.Nevertheless, it could be hypothesized that: the reply crt-p switched in magnet mode, upon detection of the static magnetic field present in the mri room.The reported twitching could be attributed to the higher ventricular output, which was delivered when the device operated in magnet mode (i.E.5 v).The elevated pacing rhythm displayed on the external ecg could have resulted from t-wave oversensing.

• 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: 12744978
• MDR Text Key: 279828854
• Report Number: 1000165971-2021-00705
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 08031527014173
• UDI-Public: (01)08031527014173(11)200727(17)220227
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• 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: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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