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

Model Number REPLY 200 DR

Device Problems Pacemaker Found in Back-Up Mode (1440); Wireless Communication Problem (3283)

Patient Problems Twitching (2172); Palpitations (2467)

Event Date 07/02/2020

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.

Event Description

Reportedly, on (b)(6) 2020, the subject device could not be interrogated with a smarttouch tablet; the manager screen was displayed with error messages due to telemetry issue but the cpr3h head leds were green.The telemetry communication was stopped as the patient complained about palpitations.The ventricular pacing was set to unipolar configuration and muscle twitching was observed.The device was interrogated with an orchestra plus and the pacemaker was found set in as-shipped mode with the warning ¿aida memory is not activated¿.The pacemaker was then reprogrammed as it was.

Manufacturer Narrative

Please refer to the updated analysis report.

Event Description

Reportedly, on (b)(6) 2020, the subject device could not be interrogated with a smarttouch tablet; the manager screen was displayed with error messages due to telemetry issue but the cpr3h head leds were green.The telemetry communication was stopped as the patient complained about palpitations.The ventricular pacing was set to unipolar configuration and muscle twitching was observed.The device was interrogated with an orchestra plus and the pacemaker was found set in as-shipped mode with the warning ¿aida memory is not activated¿.The pacemaker was then reprogrammed as it was.

• Brand Name: REPLY 200
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 10321208
• MDR Text Key: 201408285
• Report Number: 1000165971-2020-00526
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012933
• UDI-Public: (01)08031527012933(11)150417(17)161117
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2016
• Device Model Number: REPLY 200 DR
• Device Catalogue Number: REPLY 200 DR
• Device Lot Number: S0079
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1