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

Model Number REPLY DR

Device Problems Pacemaker Found in Back-Up Mode (1440); Loss of Data (2903)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

Reportedly, during a follow-up performed on (b)(6) 2021, the subject pacemaker was found in standby mode and needed to be re-initialized.In addition, the battery curve was found empty.

Event Description

Reportedly, during a follow-up performed on 07 january 2021, the subject pacemaker was found in standby mode and needed to be re-initialized.In addition, the battery curve was found empty.

Manufacturer Narrative

Preliminary analysis results confirmed the reported switch in standby mode.It was most probably due to a single event upset (seu).Normal pacemaker operation was restored by device re-initialization performed on (b)(6)2021.The battery curve was also re-initialized, which complies with specifications.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during a follow-up performed on (b)(6) 2021, the subject pacemaker was found in standby mode and needed to be re-initialized.In addition, the battery curve was found empty.

• 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: 11249577
• MDR Text Key: 230544779
• Report Number: 1000165971-2021-00247
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527008882
• UDI-Public: (01)08031527008882(11)150122(17)160822
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2021

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: 08/22/2016
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 04/22/2021
• Supplement Dates FDA Received: 03/05/2021; 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1