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 Application Program Problem (2880); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

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) 2018, the pacemaker was found in unipolar configuration at implantation.

Event Description

On (b)(6) 2018, the pacemaker was interrogated before implantation to disable the automatic detection of implantation function.Reportedly, it was not possible to reprogram the pacemaker in unipolar configuration.

Manufacturer Narrative

Please refer to the attached analysis report.

Manufacturer Narrative

Preliminary analysis results could not confirm the reported behavior; no attempt to reprogram the pacemaker in unipolar configuration was recorded.

Event Description

On (b)(6) 2018, the pacemaker was interrogated before implantation to disable the automatic detection of implantation function.Reportedly, it was not possible to reprogram the pacemaker in unipolar configuration.

• 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: 7519132
• MDR Text Key: 108804784
• Report Number: 1000165971-2018-00496
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527013138
• UDI-Public: (01)08031527013138(11)180110(17)190810
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2019
• Device Model Number: REPLY 200 DR
• Device Catalogue Number: REPLY 200 DR
• Device Lot Number: S0296
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2018
• Event Location: Hospital
• Date Manufacturer Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1