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

Model Number REPLY CRT-P

Device Problem No Pacing (3268)

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

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by livanova that was cleared or approved by fda for marketing in the united states.

Event Description

During a crt-d device replacement after disconnecting the rv lead and reconnection in the subject device the physician stopped the lv pacing.There was no pacing of the rv for about 7 seconds.The device was outside the pocket.Then, lv pacing was reactivated and pacing rate was set to 50 bpm.Pacing morphology became rv pacing with a rate of 70 (which should be the reply pacing at 70 bpm).Then the lv was connected to the reply.During this, several short periods of pacing inhibition, were visible.The device was put in the pocket which showed changing of the pacing spike (unipolar pacing).

Manufacturer Narrative

Preliminary analysis showed no ecg to prove the lack of pacing but it's probably associated to noise when pm not yet in pocket/body and especially in the hands of physician.

Event Description

During a crt-d device replacement after disconnecting the rv lead and reconnection in the subject device the physician stopped the lv pacing.There was no pacing of the rv for about 7 seconds.The device was outside the pocket.Then, lv pacing was reactivated and pacing rate was set to 50 bpm.Pacing morphology became rv pacing with a rate of 70 (which should be the reply pacing at 70 bpm).Then the lv was connected to the reply.During this, several short periods of rv pacing inhibition, were visible.The device was put in the pocket which showed changing of the pacing spike (unipolar pacing).

Manufacturer Narrative

Please refer to the analysis report.

Event Description

During a crt-d device replacement after disconnecting the rv lead and reconnection in the subject device the physician stopped the lv pacing.There was no pacing of the rv for about 7 seconds.The device was outside the pocket.Then, lv pacing was reactivated and pacing rate was set to 50 bpm.Pacing morphology became rv pacing with a rate of 70 (which should be the reply pacing at 70 bpm).Then the lv was connected to the reply.During this, several short periods of rv pacing inhibition, were visible.The device was put in the pocket which showed changing of the pacing spike (unipolar pacing).

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 7027687
• MDR Text Key: 92739537
• Report Number: 1000165971-2017-00844
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 08031527014173
• UDI-Public: (01)08031527014173(11)160531(17)171231
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2017

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: 12/31/2017
• Device Model Number: REPLY CRT-P
• Device Catalogue Number: REPLY CRT-P
• Device Lot Number: S0191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 12/27/2017; 01/24/2018
• Supplement Dates FDA Received: 01/23/2018; 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1