MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY 200; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number REPLY 200 DR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pocket Erosion (2013)

Event Date 09/01/2021

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.The device was implanted on (b)(6) 2017.Please note that implantation date has been selected as the expiration date (22 december 2016) due to system limitation.

Event Description

The subject pacemaker was implanted on (b)(6) 2017.Reportedly, on (b)(6) 2021, the pacemaker was exposed due to compression necrosis in the pacemaker pocket site.A new pacemaker was implanted on the opposite side on (b)(6) 2021 and the subject pacemaker was explanted on 3 september 2021.The inside of the pocket was cleaned and the leads were capped and abandoned.It was reported that the tissue culture was negative, denying infection.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The subject pacemaker was implanted on (b)(6) 2017.Reportedly, on (b)(6) 2021, the pacemaker was exposed due to compression necrosis in the pacemaker pocket site.A new pacemaker was implanted on the opposite side on (b)(6) 2021 and the subject pacemaker was explanted on (b)(6) 2021.The inside of the pocket was cleaned and the leads were capped and abandoned.It was reported that the tissue culture was negative, denying infection.

• Brand Name: REPLY 200
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 12566350
• MDR Text Key: 274428876
• Report Number: 1000165971-2021-00662
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012933
• UDI-Public: (01)08031527012933(11)150522(17)161222
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/11/2022

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: 12/22/2016
• Device Model Number: REPLY 200 DR
• Device Catalogue Number: REPLY 200 DR
• Device Lot Number: S0083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2015
• 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