MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ESPRIT S

Device Problem Over-Sensing (1438)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr 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, during a follow-up performed on (b)(4) 2021 on the subject pacemaker, noise oversensing was observed.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during a follow-up performed on 04 january 2021 on the subject pacemaker, noise oversensing was observed.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11257270
• MDR Text Key: 230544416
• Report Number: 1000165971-2021-00252
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527009179
• UDI-Public: (01)08031527009179(11)200406(17)211106
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: ESPRIT S
• Device Catalogue Number: ESPRIT S
• Device Lot Number: S0445
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1