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

Model Number REPLY 200 DR

Device Problem Over-Sensing (1438)

Patient Problem No Information (3190)

Event Date 01/04/2021

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

Reportedly, the subject pacemaker revealed noise oversensing on the atrial channel.Preliminary analysis confirmed that several episodes showing atrial noise oversensing were recorded in the device memory.The observed noise could have resulted from electromagnetic interferences (emi) and/or myopotentials sensing.However, a beginning of an atrial lead issue could not be excluded.

Event Description

Reportedly, the subject pacemaker revealed noise oversensing on the atrial channel.Preliminary analysis confirmed that several episodes showing atrial noise oversensing were recorded in the device memory.The observed noise could have resulted from electromagnetic interferences (emi) and/or myopotentials sensing.However, a beginning of an atrial lead issue could not be excluded.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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
• MDR Report Key: 11327830
• MDR Text Key: 233743868
• Report Number: 1000165971-2021-00291
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2014
• Device Model Number: REPLY 200 DR
• Device Catalogue Number: REPLY 200 DR
• Device Lot Number: 2714
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2021
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1