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 Premature Discharge of Battery (1057)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2021

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 resynchronization system was implanted on (b)(6) 2017.Reportedly, premature battery depletion occurred.The crt-p was replaced on (b)(6) 2021 since it had reached its end of service (eos).

Event Description

The resynchronization system was implanted on (b)(6) 2017.Reportedly, premature battery depletion occurred.The crt-p was replaced on 30 june 2021 since it had reached its end of service (eos).

• 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: 12225183
• MDR Text Key: 263405028
• Report Number: 1000165971-2021-00574
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 08031527014173
• UDI-Public: (01)08031527014173(11)160411(17)171111
• 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: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2017
• Device Model Number: REPLY CRT-P
• Device Catalogue Number: REPLY CRT-P
• Device Lot Number: S0171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• 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