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

Model Number ESPRIT DR

Device Problems Inappropriate or Unexpected Reset (2959); Missing Test Results (3267)

Patient Problems Tachycardia (2095); Ventricular Tachycardia (2132)

Event Date 11/13/2020

Event Type  malfunction  

Event Description

Reportedly, the subject (b)(6) dr was implanted on (b)(6) 2020 but aida memories could not be activated, neither on (b)(6) 2020 when interrogating the device with an orchestra programmer.A test was made with another (b)(6) dr still in the box using an orchestra plus and a smarttouch tablet with different programmer software versions and it was not possible to program the aida memories either.Usually, when first programming the pacemaker after the implantation, the message 'aida memories not activated.Do you want to activate it? yes ¿ no' is displayed.On (b)(6) 2020, instructions were provided to activate aida memories.The file dated (b)(6) 2020 showed data from (b)(6) 2020, so the activation of the aida memories was deemed effective since the implantation.In the evening of (b)(6) 2020, the patient underwent an external cardioversion of a wide-complex tachycardia.When interrogating the device on (b)(6) 2020, no statistics were present, aida memories were reset.It was suspected that it was a consequence of the cardioversion.Additionally, the doctors observed for some patients that the test results were not present in the printouts (the test results were saved by pressing the 'save' button).

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the subject esprit dr was implanted on (b)(6) 2020 but aida memories could not be activated, neither on (b)(6) 2020 when interrogating the device with an orchestra programmer.A test was made with another esprit dr still in the box using an orchestra plus and a smarttouch tablet with different programmer software versions and it was not possible to program the aida memories either.Usually, when first programming the pacemaker after the implantation, the message 'aida memories not activated.Do you want to activate it? "yes - no" is displayed.On (b)(6) 2020, instructions were provided to activate aida memories.The file dated (b)(6) 2020 showed data from (b)(6) 2020, so the activation of the aida memories was deemed effective since the implantation.In the evening of (b)(6) 2020, the patient underwent an external cardioversion of a wide-complex tachycardia.When interrogating the device on (b)(6) 2020, no statistics were present, aida memories were reset.It was suspected that it was a consequence of the cardioversion.Additionally, the doctors observed for some patients that the test results were not present in the printouts (the test results were saved by pressing the 'save' button).

Manufacturer Narrative

Preliminary analysis results showed that the device behaved as specified.

Event Description

Reportedly, the subject esprit dr was implanted on (b)(6) 2020 but aida memories could not be activated, neither on (b)(6) 2020 when interrogating the device with an orchestra programmer.A test was made with another esprit dr still in the box using an orchestra plus and a smarttouch tablet with different programmer software versions and it was not possible to program the aida memories either.Usually, when first programming the pacemaker after the implantation, the message 'aida memories not activated.Do you want to activate it? yes ¿ no' is displayed.On (b)(6) 2020, instructions were provided to activate aida memories.The file dated 16 nov 2020 showed data from (b)(6) 2020, so the activation of the aida memories was deemed effective since the implantation.In the evening of (b)(6) 2020, the patient underwent an external cardioversion of a wide-complex tachycardia.When interrogating the device on (b)(6) 2020, no statistics were present, aida memories were reset.It was suspected that it was a consequence of the cardioversion.Additionally, the doctors observed for some patients that the test results were not present in the printouts (the test results were saved by pressing the 'save' button).

• 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: 10958350
• MDR Text Key: 220658989
• Report Number: 1000165971-2020-00783
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527017419
• UDI-Public: (01)08031527017419(11)200522(17)211222
• 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: 03/23/2021

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: 12/22/2021
• Device Model Number: ESPRIT DR
• Device Catalogue Number: ESPRIT DR
• Device Lot Number: S0449
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/13/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/18/2021; 03/10/2021
• Supplement Dates FDA Received: 02/12/2021; 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1